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
A certified QM system secures you long-term market advantages. With a certified QM system, you are ideally positioned to succeed in the market.
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.
We have helped these customers gain a competitive edge
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.
We are the "Experts in Certification"
Because we at MEDAGENT can draw on around 20 years of experience in the certification of quality management systems. Although we are not an accredited certification company, we are happy to advise you on your path to QM certification - that is our core competence.
QM systems
Our consulting services in the area of quality management range from the implementation and maintenance of the QM system to its revision in the event of upcoming changes to laws, standards or regulations.
The conformity of your processes offers the opportunity to be competitive in the long term. With the help of an intact QM system, you can create clear and transparent processes in the company, which increase profitability, minimize errors and thus the entrepreneurial risk and thus increase customer satisfaction and employee motivation in the long term.
Certification of your QM system
Together with our team, we will put you on the right track or, if necessary, set additional courses so that the goal of compliance with a wide range of normative and legal requirements can be achieved.
Our focus here is on the field of medical technology and the associated European standard, DIN ISO 13485. Comparable internationally applicable regulations naturally pose no challenge for us. These include, in particular, 21 CFR Part 820 (USA) and Therapeutic Goods (Medical Devices) Regulations 2002 - Schedule 3 (Australia), RDC ANVISA n. 16/2013 (Brazil) or MHLW Ministerial Ordinance No. 169 (Japan).
Thanks to our proximity to small and medium-sized companies, we also have cross-industry experience based on EN ISO 9001.
However, certification does not mean ...
Certification is not based on a rigid set of rules that constrict the company for the next few years. Rather, it is an essential component of the company's success and helps it to react agilely to market changes. As markets become increasingly dynamic, the requirements placed on medical products in terms of safety, quality and customer satisfaction are developing ever faster. For this reason, we believe that the most important characteristic of a good quality management system is the ability to react flexibly to changes. The flexibility of processes and production procedures is of fundamental importance in order to optimally control the quality of the product.
With our help and support, you can lay the foundations for this necessary flexibility and for passing your audit and placing your medical devices on the market in a timely manner.
Get started now with MEDAGENT
Internal audits
Regardless of the European or international market in which you want to sell or market your medical device, an internal audit is the first step in checking the extent to which your products and processes comply with national standards and laws for medical devices.
In order to be able to sell your medical device on the European market, you as a manufacturer must undergo a conformity assessment procedure. As an essential part of the conformity assessment procedure, manufacturers of medical devices must submit technical documentation to a notified body. Based on these documents, the notified bodies audit compliance with basic safety and performance requirements and thus the marketability of the medical device.
In addition to the technical documentation, the legal manufacturer must introduce a quality management system that also meets the requirements of the Medical Device Directive and the Medical Device Regulation and is checked by the auditors.
But even if you are not a manufacturer within the meaning of the Medical Device Regulation, but rather a contract manufacturer and extended workbench that manufactures to customer specifications, the best way to ensure compliance with normative and customer requirements is to conduct an internal audit.
This is how we support you as part of an internal audit:
External audits
In the external audit, you can withstand the comprehensive review and meet all the necessary standard requirements that are placed on your quality management system to be certified. - This is our common goal.
Our consultants do not accompany you as "watchdogs", but as coaches and supporters. Our aim is to provide you with appropriate and professional support. To do this, we use our holistic view of your company. We want to help you drive your company forward and work with you to answer the auditors' questions so that you pass the certification audit.
The audit is followed by a joint review of the audit results. If necessary, we will support you with the subsequent root cause analysis and corrective measures. Finally, we carry out an effectiveness check on the corrective measures implemented so that you are ideally positioned for the future.
In order to be able to sell your medical device on the European market, you as a manufacturer must undergo a conformity assessment procedure. As an essential part of the conformity assessment procedure, manufacturers of medical devices must submit technical documentation to a notified body. Based on these documents, the notified bodies audit compliance with basic safety and performance requirements and thus the marketability of the medical device.
In addition to the technical documentation, the legal manufacturer must introduce a quality management system that also meets the requirements of the Medical Device Directive and the Medical Device Regulation and is checked by the auditors.
But even if you are not a manufacturer within the meaning of the Medical Device Regulation, but a contract manufacturer and extended workbench that manufactures to customer specifications, the best way to ensure compliance with normative and customer requirements is to conduct an internal audit.
We support you in all matters relating to approval and facilitate market access for your medical devices! Contact us today!
MDSAP
Are you already familiar with MDSAP?
"MDSAP" stands for Medical Device Single Audit Program and, in times of globalization and internationalization, is a sensible merger of official requirements from Europe, the USA, Canada, Brazil, Japan and Australia in order to standardize the approval process for medical devices and the associated conformity assessments and necessary audits.
Through our branches in the USA and Brazil, we have already gained experience in carrying out inspections by the FDA or ANVISA.
Our team will support you in implementing the country-specific requirements resulting from the MDSAP. From the initial GAP analysis, through implementation with your colleagues and employees, to continuous further development. We are also happy to be at your side during the four to five-day on-site audit by the notified body.