Medical Devices Challenges
Unlike other products, a medical device is subject to deep levels of oversight to ensure it is safe and effective. The medical device requires design inputs, design outputs, verification, clinical trials and validation before submittal to the FDA for clearance. A successful medical device product development partner must have a deep level of understanding of what’s required for compliance with IEC 60601, IEC 62304, ISO 13485 and know how to ensure your products will pass emission and various agency testing for UL and CE marking. Selecting a development partner for your outsourced medical device project that lacks this understanding can result in a device that is incapable of achieving compliance to FDA standards.
Why Resolution for Medical Device Product Development
Resolution Development Services specializes in Medical Device product development projects. We have a quality management system which is ISO 13485 compliant and has been audited by Fortune 500 companies and in certain cases our QMS was selected for our customer’s product development program. We take great pride in ensuring that our quality management system stays up to date, that our employees are trained to our quality system, and as a company, we are always looking for ways to improve our processes.