Ihr Agent für GMP, Qualitäts-management & Prozessoptimierung von Medizin-produkten
Your agent for GMP, quality management & process optimization of medical devices
We support you in securing long-term competitive advantages by implementing efficient and compliant quality management systems (QM systems). With around 20 years of experience in the certification of QM systems, we are your experts in this field.
Competitive Advantages
Ein zertifiziertes QM-System sichert Ihnen langfristige Marktvorteile. Mit einem zertifizierten QM-System sind Sie bestens aufgestellt, um im Markt erfolgreich zu bestehen.
Error Avoidance
Structured processes minimize errors. Clear and transparent processes help to avoid errors and increase efficiency.
Customer Satisfaction
Satisfied customers thanks to consistently high product quality. An intact QM system ensures that your customers always receive high-quality products.
Employee Motivation
Clear processes and responsibilities promote the motivation of your employees. Structured work also increases the satisfaction and performance of your employees.
Diesen Kunden haben wir zu Wettbewerbsvorteilen verholfen
Our services
Implementation of QM systems
We support you in implementing a new quality management system that meets all regulatory requirements. Our team of experts will guide you through the entire process - from planning and implementation through to successful certification. With a tailor-made strategy, we ensure that your QM system is efficient, compliant and optimally integrated into your existing business processes.
Maintenance & Revision
We support you in adapting your existing quality management system to new regulations. Our experts analyze your current processes, identify necessary optimizations and develop tailor-made solutions to ensure compliance. In this way, we ensure that your QM system is always up to date and efficiently complies with the applicable regulations.
Internal Audits & GAP Analyses
We carry out comprehensive audits to precisely analyze the current status of your quality management system and check its compliance with applicable regulatory requirements. In doing so, we specifically identify potential for improvement and develop practical recommendations for action in order to sustainably optimize efficiency and compliance. In this way, we ensure that your QM system remains successful in the long term.
Preparation & Monitoring of External Audits
We prepare your company specifically for external audits. Our team of experts is on hand to advise you throughout the entire audit process to ensure that all regulatory requirements are met. With our professional guidance and practical support, we enable you to have a smooth audit and a successful conclusion with the best possible results.
Quality Management
Experts in Certification
With over 25 years of experience in consulting and certifying quality management systems, we can provide you with expert support on your path to QM certification – even if we are not an accredited certification body ourselves.
We support you in the implementation, optimization and continuous adaptation of your QM system to legal, normative and regulatory requirements. An efficient QM system creates transparent processes, increases profitability, minimizes risks and contributes to the long-term satisfaction of your customers and employees.
Our team ensures that your company complies with the relevant regulatory requirements, particularly in the field of medical technology and DIN EN ISO 13485. We also have in-depth experience with international regulations such as 21 CFR Part 820 (USA), Therapeutic Goods (Australia), RDC ANVISA (Brazil) and MHLW (Japan) as well as with EN ISO 9001 across all industries.
A certified quality management system is not a rigid regulation, but a strategic instrument for sustainable corporate success. It enables flexible adaptation to dynamic market requirements and guarantees consistently high product quality. We help you to create this basis – for a successful audit and the safe market launch of your medical devices.
Internal Audits
An internal audit is the first crucial step in ensuring that your medical devices and processes comply with applicable national and international standards and regulatory requirements – regardless of the target market.
For distribution in Europe, manufacturers must undergo a conformity assessment procedure and submit complete technical documentation to a notified body. This body checks whether all safety and performance requirements are met.
In addition, the implementation of a quality management system that complies with the requirements of the Medical Device Regulation (MDR) or the In Vitro Diagnostics Regulation (IVDR) is required. This system is regularly reviewed through internal and external audits to ensure continuous compliance.
Contract manufacturers also benefit from internal audits, as they can optimally demonstrate compliance with normative and customer-specific requirements and identify potential for improvement.
External Audits
An external audit assesses the conformity of your quality management system with the applicable standard requirements. Our aim is to optimally prepare you for this and ensure that you successfully pass the certification.
Our consultants act as competent guides, not inspectors. They support you during the audit, answer the auditors’ questions together with you and help you to master potential challenges with confidence. Once the audit is complete, we analyze the results together, identify possible deviations and initiate targeted corrective measures – including an effectiveness check.
A conformity assessment procedure is required for the European market. Manufacturers must submit complete technical documentation to a notified body, which checks whether the safety and performance requirements are met.
In addition, a quality management system must be implemented in accordance with the requirements of the Medical Device Regulation (MDR) or the In Vitro Diagnostics Regulation (IVDR). This system is regularly reviewed through internal and external audits.
The best way for contract manufacturers to ensure compliance with normative and customer-specific requirements is through an internal audit.
MDSAP
The Medical Device Single Audit Program (MDSAP) simplifies the global approval process for medical devices by harmonizing regulatory requirements from Europe, the USA, Canada, Brazil, Japan and Australia. With this program, manufacturers can meet their approval requirements through a single audit, saving time and resources.
Thanks to our subsidiaries in the USA and Brazil, we have extensive experience with FDA and ANVISA inspections and can therefore offer you competent and efficient support in carrying out the MDSAP audit to successfully approve your products worldwide.
Reaching the Goal Together - your path to Certification
Process Optimization
Processes can vary in complexity and often require step-by-step optimization based on a deep understanding of the relevant standards, laws and regulations. It is equally important to consider the organization’s capabilities, resources and technologies in order to develop efficient solutions.
The first step is a gap assessment or audit in which both existing gaps and stable processes are identified. On this basis, the target state is defined, taking into account the requirements for team size and specific support – whether as moderation, leadership or direct hands-on measures. Tasks are clearly defined and, if necessary, implemented using agile methods such as Kanban or Scrum. Browser-based apps ensure that everyone involved is always up to date and transparent communication is guaranteed.
The performance review continuously checks whether all tasks have been completed and whether employees are working successfully with the new processes. Optimizations are carried out step by step according to the plan-do-check-act cycle to ensure sustainable efficiency and continuous improvement.
MEDAGENT COMPLY
Your guide to regulatory compliance monitoring
MEDAGENT COMPLY offers companies comprehensive and continuous regulatory compliance monitoring, ensuring that all relevant legal requirements are always met.
Validation
Do your validated processes, software and methods need a comprehensive update? Or are you facing the challenge of implementing the validation of your processes for the first time? Our experts develop customized and efficient validation strategies to ensure the safety and functionality of your medical devices. We support you in the planning, implementation and control of all processes requiring validation, create detailed procedures and work instructions and define precise acceptance criteria. In addition, we offer expert support in determining the sample size and handle communication with notified bodies and testing laboratories to ensure smooth validation and compliance.
Process Validation
We support you in proving that your manufacturing processes work reliably throughout the entire product life cycle – even under the most demanding conditions. Our approach is based on the V-model, which enables structured and comprehensive validation. Our aim is to establish a robust and reliable process that meets the highest quality standards.
The validation process comprises the following steps:
Identification and analysis: In this first step, we analyze and document your current processes and develop a customized validation strategy that is tailored to your specific requirements.
Planning: Together with our technical experts, we create a validation-optimized plan that forms the basis for implementation. This plan ensures efficient and standard-compliant implementation of the validation.
Software Validation
We qualify your IT infrastructure and validate software applications to ensure that they meet the highest standards. Working closely with your quality management team and IT department, we review the software systems in terms of their effectiveness and impact on the medical device. Our experts validate both the software applications and the software used in active medical devices.
As part of this process, we create a comprehensive validation plan that ensures that all relevant requirements of the DIN EN ISO 13485 and GAMP5 standards and the Medical Device Regulation (MDR) are met. We guarantee seamless documentation and implementation to ensure high product quality and compliance.
Method Validation
For non-standardized methods in quality control, such as the validation of measuring systems and test equipment, we offer precise analysis and optimization. We check the performance of your measuring systems and test equipment using the established Gauge R&R procedures 1 and 2. These procedures ensure that your measuring systems are reliable and accurate to ensure the quality of your medical devices throughout the entire production process.
Our aim is to provide you with a well-founded and practice-oriented validation that meets the high requirements of medical technology and ensures compliance with international standards and regulations.
MEDAGENT VALIGUARD
Validations - always compliant, always up-to-date.
Our periodic monitoring service ensures that validations always comply with current regulatory requirements. At the same time, it enables continuous optimization of processes, software and methods – for maximum efficiency and compliance.
We are "Experts in Certification"
Competitive Advantages
Sustainable market advantages through the strength of a certified QM system.
Error Avoidance
Error prevention through clearly defined and optimized processes.
Customer Satisfaction
Customer satisfaction as a result of consistent quality and precision.
Employee Motivation
Responsibility and structure - the way to more motivation in the team.
Cost Savings
Process optimization as the key to reducing operating costs and errors.
Compliance Security
Secure your market access by meeting all relevant legal and normative requirements.
Flexibility
Rely on an agile strategy to efficiently manage market changes and new requirements.
Long-Term Partnership
MEDAGENT accompanies you all the way to lasting success and growth.
Case studies: Our success stories
Express process validation in 2 weeks: How MEDAGENT successfully successfully guided a company through the strict requirements
Background
A medium-sized medical device company was faced with the challenge of validating a new manufacturing process within just two weeks. This placed high demands on planning, teamwork and compliance with regulatory requirements.
Initial situation
- Time frame: Only 2 weeks for the entire process validation
- Team: 5 employees from the areas of quality assurance, production, technology and the experts from MEDAGENT
- Challenges:
- Tight time frame for validation
- Complex manufacturing process with numerous variables
- Compliance with strict regulatory requirements
Solution: Efficient strategy for process validation
In order to successfully complete the validation within the short deadline, MEDAGENT relied on a structured and focused approach:
- Efficient teamwork and clear communication
- Short daily meetings to assess progress and quickly clarify open points
- Clear distribution of tasks via ClickUp to ensure transparency and efficiency
- Parallelization of tasks to save time
- Simultaneous execution of documentation and practical tests to avoid time losses
- Close coordination between the teams to minimize delays
- Focus on critical aspects
- Prioritization of the most important process parameters and quality attributes
- Avoiding unnecessary complexity through targeted validation strategies
- Use of experienced specialists
- Validation by experts with extensive experience to minimize sources of error
- Quick identification and resolution of potential challenges
Results
Successful completion of process validation in 2 weeks
- Successful completion of the process validation within the set deadline of 2 weeks
- All defined acceptance criteria were met
- No critical deviations during the validation runs
- Complete and regulatory compliant documentation for official inspections
Success factors
- Thorough preparation and detailed planning are crucial for fast and efficient implementation.
- Focusing on critical process parameters saves time without compromising quality.
- Digital tools such as ClickUp facilitate task management and speed up the validation process.
- Continuous communication within the team ensures a smooth process and prevents delays.
Conclusion
Thanks to a clear structure, targeted prioritization and the use of experienced experts, MEDAGENT was able to successfully complete the process validation in just 2 weeks – without compromising on quality and regulatory compliance. This case study shows that efficient planning, digital tools and close collaboration can lead to a successful implementation even under time pressure.
Successful FDA inspection without complaints - optimal preparation with MEDAGENT
Background
A medium-sized medical device company was faced with the challenge of successfully passing an upcoming FDA inspection. In order to be optimally prepared, the company decided to have MEDAGENT carry out a MOCK audit, followed by targeted support during the actual inspection.
Challenges
- Ensuring FDA compliance in all relevant areas
- Identification and elimination of potential weak points before the official inspection
- Sensitization and training of employees for the audit process
- Rapid implementation of necessary corrective measures
Solution: Structured preparation with MEDAGENT
- Carrying out a realistic MOCK audit
- MEDAGENT carried out a comprehensive audit simulation under real conditions in order to uncover potential problem areas at an early stage.
- Particular weaknesses were identified in the documentation of development processes and in the CAPA system.
- Creation of a detailed action plan
- Based on the audit results, MEDAGENT developed a clearly structured action plan to systematically improve all outstanding issues.
- Prioritized optimizations were implemented within a very short time.
- Intensive training for employees
- MEDAGENT organized targeted training for the relevant teams to clearly communicate the FDA requirements.
- Particular emphasis was placed on documentation processes, CAPA systems and regulatory compliance.
- Professional support during the inspection
- MEDAGENT supported the company as a strategic partner during the official FDA inspection.
- Proactive communication with the inspectors ensured transparent and structured implementation.
Results
FDA inspection without objections
- No Form FDA 483 – no significant deviations were identified.
- No “discussion items” – the inspector saw no reason for further discussion.
- Rating: “No Action Indicated” (NAI) – the best possible result for an FDA inspection.
Success factors
- Thorough preparation through a realistic MOCK audit with targeted weak-point analysis.
- Fast and effective implementation of the identified improvements.
- Comprehensive training and sensitization of all employees involved.
- Assistance from experienced consultants who supported the company throughout the entire process.
- Proactive, transparent communication with FDA inspectors to ensure a smooth inspection process.
Conclusion
Thanks to the targeted preparation with MEDAGENT, the company was able to complete the FDA inspection with the best possible result. This case study shows that a structured approach, realistic audits and early action are crucial for successful FDA compliance.
Wir sind die „Experts in Certification“
Denn wir als MEDAGENT können auf rund 20 Jahre Erfahrung bei der Zertifizierung von Qualitätsmanagement-Systemen zurückgreifen. Wir sind zwar keine akkreditierte Zertifizierungsgesellschaft, beraten Sie aber gerne auf Ihrem Weg zum QM-Zertifikat – Das ist unsere Kernkompetenz.
QM- Systemen
Unsere Beratungsleistung im Bereich Qualitätsmanagement erstreckt sich von der Implementierung und Aufrechterhaltung des QM-Systems, bis hin zu dessen Überarbeitung bei anstehenden Änderungen von Gesetzen, Normen oder Verordnungen.
Die Konformität Ihrer Prozesse bietet die Möglichkeit langfristig wettbewerbsfähig zu sein. Mit Hilfe eines intakten QM-Systems können Sie klare und transparente Abläufe im Unternehmen schaffen, welche die Wirtschaftlichkeit erhöhen, Fehler und damit das unternehmerische Risiko minimieren und somit langfristig die Kundenzufriedenheit und auch die Mitarbeitermotivation steigern.
Zertifizierung Ihres QM-Systems
Gemeinsam mit unserem Team bringen wir Sie auf den richtigen Weg oder stellen bei Bedarf zusätzliche Weichen, sodass das Ziel der Konformität zu unterschiedlichsten normativen und gesetzlichen Anforderungen erreicht werden kann.
Unser Schwerpunkt liegt hierbei im Bereich der Medizintechnik und der damit verbundenen Europäischen Norm, der DIN ISO 13485. Vergleichbare international anwendbare Regularien stellen für uns selbstverständlich keine Herausforderung dar. Hierzu gehören im Besonderen der 21 CFR Part 820 (USA) sowie Therapeutic Goods (Medical Devices) Regulations 2002 – Schedule 3 (Australien), RDC ANVISA n. 16/2013 (Brasilien) oder MHLW Ministerial Ordinance No.169 (Japan).
Durch unsere Nähe zu kleinen und mittelständischen Unternehmen verfügen wir zudem über branchenübergreifende Erfahrungen, basierend auf der EN ISO 9001.
Was Zertifizierung allerdings nicht bedeutet …
Eine Zertifizierung basiert nicht auf einem starren Regelkorsett, welches das Unternehmen die nächsten Jahre einschnürt. Sie ist vielmehr essentieller Bestandteil des Unternehmenserfolgs und hilft agil auf Marktveränderungen zu reagieren. Durch die fortschreitende Dynamik der Märkte entwickeln sich die Anforderungen an Medizinprodukte im Bezug auf die Sicherheit, die Qualität und auch die Kundenzufriedenheit immer schneller. Aus diesem Grund sind wir der Meinung, dass die wichtigste Eigenschaft eines guten Qualitätsmanagement-Systems in der flexiblen Reaktion auf Veränderungen liegt. Um die Qualität des Produktes optimal zu lenken, ist die Flexibilität der Prozesse und Produktionsabläufe von elementarer Bedeutung.
Mit unserer Hilfe und Unterstützung legen Sie den Grundstein für diese erforderliche Flexibilität sowie für das damit einhergehende Bestehen Ihres Audits und für das zeitnahe Inverkehrbringen Ihrer Medizinprodukte.
Jetzt durchstarten mit MEDAGENT
Interne Audits
Egal in welchem europäischen oder internationalen Markt Sie Ihr Medizinprodukt verkaufen oder in Verkehr bringen möchten – ein internes Audit ist der erste Schritt zur Überprüfung, inwieweit Ihre Produkte und Prozesse den nationalen Normen und Gesetzen für Medizinprodukte entsprechen.
Um Ihr Medizinprodukt auf dem europäischen Markt vertreiben zu können, müssen Sie als Hersteller ein Konformitätsbewertungsverfahren durchlaufen. Als wesentlicher Bestandteil des Konformitätsbewertungsverfahrens müssen Hersteller von Medizinprodukten eine Technische Dokumentation bei einer Benannten Stelle einreichen. Die Benannten Stellen auditieren auf Basis dieser Dokumente die Einhaltung grundlegender Sicherheits- und Leistungsanforderungen und damit die Verkehrsfähigkeit des Medizinproduktes.
Neben der Technischen Dokumentation muss der legale Hersteller ein Qualitätsmanagement-System einführen, das ebenfalls den Anforderungen der Medizinprodukterichtlichtlinie bzw. der Medizinprodukteverordnung entspricht und von den Auditoren überprüft wird.
Aber auch wenn Sie kein Hersteller im Sinne der Medizinprodukteverordnung sind, sondern als Lohnhersteller und verlängerte Werkbank nach Kundenspezifikationen fertigen, lässt sich die Übereinstimmung der normativen und kundenseitigen Anforderungen am besten über ein internes Audit sicherstellen.
So unterstützen wir Sie im Rahmen eines internen Audits:
Externe Audits
Im externen Audit können Sie der umfassenden Überprüfung standhalten und erfüllen alle notwendigen Normenanforderungen, die an Ihr zu zertifizierendes Qualitätsmanagementsystem gestellt werden. – Das ist unser gemeinsames Ziel.
Unsere Berater begleiten Sie dabei nicht als „Aufpasser“, sondern als Coach und Unterstützer. Unser Anspruch ist es, Sie sachgemäß und professionell zu begleiten. Hierfür nutzen wir unseren ganzheitlichen Blick auf Ihr Unternehmen. Wir möchten Sie dabei unterstützen, Ihr Unternehmen voranzutreiben und gemeinsam mit Ihnen die Fragen der Auditoren beantworten, sodass Sie das Zertifizierungsaudit bestehen.
Im Anschluss an das Audit folgt ein gemeinsames Review der Auditergebnisse. Falls notwendig, unterstützen wir Sie im Nachgang bei der durchzuführenden Ursachenanalyse sowie bei Korrekturmaßnahmen. Abschließend führen wir eine Wirksamkeitsprüfung zu den durchgeführten Korrekturmaßnahmen durch, sodass Sie für die Zukunft bestens aufgestellt sind.
Um Ihr Medizinprodukt auf dem europäischen Markt vertreiben zu können, müssen Sie als Hersteller ein Konformitätsbewertungsverfahren durchlaufen. Als wesentlicher Bestandteil des Konformitätsbewertungsverfahrens müssen Hersteller von Medizinprodukten eine Technische Dokumentation bei einer Benannten Stelle einreichen. Die Benannten Stellen auditieren auf Basis dieser Dokumente die Einhaltung grundlegender Sicherheits- und Leistungsanforderungen und damit die Verkehrsfähigkeit des Medizinproduktes.
Neben der Technischen Dokumentation muss der legale Hersteller ein Qualitätsmanagement-System einführen, das ebenfalls den Anforderungen der Medizinprodukterichtlichtlinie bzw. der Medizinprodukteverordnung entspricht und von den Auditoren überprüft wird.
Aber auch wenn Sie kein Hersteller im Sinne der Medizinprodukteverordnung sind, sondern als Lohnhersteller und verlängerte Werkbank nach Kundenspezifikationen fertigen, lässt sich die Übereinstimmung der normativen und kundenseitigen Anforderungen am Besten über ein internes Audit sicherstellen.
Wir unterstütze Sie in allen Belangen rund um die Zulassung und erleichtern Ihnen den Markzugang für Ihre Medizinprodukte! Fragen Sie uns heute noch an!
MDSAP
Ist Ihnen MDSAP bereits ein Begriff?
„MDSAP“ steht für Medical Device Single Audit Programm und ist in Zeiten von Globalisierung und Internationalisierung ein sinnvoller Zusammenschluss behördlicher Anforderungen von Europa, USA, Kanada, Brasilien, Japan und Australien, um den Zulassungsprozess von Medizinprodukten sowie die damit verbundenen Konformitätsbewertungen und notwendigen Audits zu vereinheitlichen.
Über unsere Niederlassungen in den USA und Brasilien haben wir bereits Erfahrung bei der Durchführung von Inspektionen durch die FDA oder die ANVISA gesammelt.
Unser Team begleitet Sie bei der Implementierung der länderspezifischen Anforderungen, welche sich aus dem MDSAP ergeben. Von der ersten GAP-Analyse, über die Umsetzung mit Ihren Kollegen und Mitarbeitern bis hin zur kontinuierlichen Weiterentwicklung. Auch während des vier- bis fünftätigen Vorort-Audits durch die Benannte Stelle sind wir gerne an Ihrer Seite.