26 Jun Medical technology sector in Switzerland

The Medical Technology Sector in Switzerland

The medical technology sector in Switzerland is characterized by continuous growth. A current challenge lies in adapting to and maintaining the constantly changing regulatory and health requirements. This includes the implementation of the EU Medical Device Regulation (MDR), which came into effect in May 2021. It entails increased requirements for clinical evidence, more extensive post-market surveillance, and greater transparency in the supply chain. Companies must ensure that their products comply with the new regulations and have the necessary documentation and certifications.

Case Study: Class III Implantable Medical Device

Concept Development and Design:

Cape7 works closely with the customer to develop a concept for the implant based on the needs of the patients and the requirements of the doctors, helping the customer select the best design option that meets the high standards of Class III medical devices.

Prototype Development and Testing:

Cape7 supports the customer in developing a prototype of the implant and conducts thorough tests to ensure that the implant meets safety, efficacy, and performance requirements. This includes conducting biocompatibility and sterilization tests, as well as risk assessment and mitigation.

Approval Process:

Cape7 guides the customer through the Premarket Approval (PMA) application process with the FDA and ensures compliance with regulations during inspections.

Production Facility and Process Development:

Cape7 assists the customer in developing and implementing production facilities and processes to ensure the manufacturing of the implant. This includes storage, packaging, and labeling of the products.

Production:

After successful FDA approval, we support our customers in optimizing production processes by applying process optimization and quality management methods to achieve efficient and high-quality production.

Post-Market Surveillance:

Cape7 collaborates with the customer to monitor safety reports and conduct follow-up studies to ensure the long-term safety and efficacy of the implant.

Product Maintenance and Updates:

Cape7 assists the customer in the regular maintenance and updating of the implant to ensure it meets the latest standards.

End of Life:

Cape7 supports the customer in decision-making regarding the discontinuation or replacement of the product at the end of its lifecycle.

Conclusion

We have an extensive track record in the GMP-regulated industry and can provide you with examples of our successfully completed projects, including details of the customer’s needs, the solutions delivered, and the results achieved. As an engineering service provider, we offer our customers our comprehensive experience and expertise in project management, lean management, and process engineering to support them in the development and entire lifecycle of their medical technology products.