What’S New Services Investments About Careers Contact Blog Work with us . " Specialized Expertise Channel decades of experience in medical device development into your new or existing products and ideas. Learn more We collaborate closely with your team in order to understand your specific needs and adapt to the demands of your project. Learn more Teamwork Integrated, visible, accessible and highly skilled team members. Integrity Maintaining consistency between our performance and our client’s expectations. Quality Quality is integral to delivering the right product on time. Team Creation Strategy Assessment Quality / Compliance / Regulatory Updates – 29 October 2021 Nov 4th, 2021 FDA / EU / Regulatory Updates FDA releases its list of proposed draft and final medical device guidance documents for fiscal year 2022 There are several medical device guidance documents related to software, cybersecurity and usability (human factors engineering). A-List: Prioritized Guidance Documents that CDRH Intends to Publish in FY2022 Final Guidance Topics […] Quality / Compliance / Regulatory Updates – 4 October 2021 Nov 4th, 2021 FDA / EU / Regulatory Updates FDA releases draft guidance “Electronic Submission Template for Medical Device 510(k) Submissions” This draft guidance describes the technical standards associated with preparation of the electronic submission template for 510(k)s that, when the guidance is finalized, will enable submission of the 510(k)s solely in electronic format. The electronic […] Quality / Compliance / Regulatory Updates – 27 August 2021 Aug 30th, 2021 FDA / EU / Regulatory Updates Over-the-Counter (OTC) Medical Devices Over-the-counter (OTC) medical devices are those that may be offered for sale directly to the consumer. To assist device manufacturers who are interested in seeking approval or clearance of OTC devices, the U.S. Food and Drug Administration (FDA) developed a new web […] Clients Partners Request your FREE customized product assessment today.