Regulatory Expertise and Practical Know-How for Your Success
Support in meeting compliance requirements for processes and products
Compliance with MDR and/or FDA regulations is essential for selling a medical device, depending on the target market. This means that, in addition to the technology that benefits patients, extensive documentation and validation are also required. I am here to support you in this process.
My focus is on quality management throughout the entire product lifecycle. I value traceability and the reusability of information and data.
Digitalized, data-driven documentation simplifies innovation, making it easier to adapt to an ever-changing market. My services are here to support you in achieving these goals.
Regulatory Strategy and Market Access
Do you have a market-ready idea?
I support you in defining the intended use of your product and identifying the corresponding regulatory requirements. Together, we will plan all the necessary steps for market access—within the EU and internationally.
Additionally, I assist you with preparing and submitting the documentation for market approval and can also handle communication with regulatory authorities, such as MDR Notified Bodies or the FDA.
Quality Management Systems for Effective Processes
ISO 13485 is the key standard for quality management systems in medical technology. A central process within it is risk management, typically based on ISO 14971. Depending on the market and product, further standards may be required, such as for instance ISO 27001, GDPR, and IEC 81001-5-1 when using software used in development and production.
I assist you in first understanding the requirements for your quality management system. Together, we will develop efficient and streamlined processes. This can include using digital applications as well as delegating responsibility to the relevant teams.
I am actively involved in the implementation of the system.
Product Development for Compliance with MDR and FDA
Specific standards guide the development of medical devices to ensure general safety and performance requirements. These depend on the technology and the intended use of the product.
For electronic and software products, standards like IEC 60601-1, IEC 62304/82304, IEC 81001-5-1, and the AI Act are essential. Biocompatibility (ISO 10993) and usability (IEC 62366) also require specific processes and special technical characteristics. These requirements must be addressed both in the QMS and product design.
I support you in implementing these standards—from requirements analysis through risk management and validation to technical documentation.
Digitalization for Compliance with MDR and FDA
Do you currently use MS Word and Excel for your documentation? Are you interested in taking advantage of digitalized processes?
Together, we will determine the requirements for your new eQMS and eTD/PLM system and select the best solution for you. I have had very positive experiences with tools from Matrix Requirements.
I also support you in introducing the new system, configuring it, and training your employees. Additionally, I handle the transfer of existing documents and adjust the document management as needed.
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Let’s work together to make your medical devices compliant and successful.