Our Experience Can Provide Immediate Answers or A Valuable On-Site Training Resource:

Training Customized For Your Needs Without Employee Travel Costs Or Unnecessary Loss of Productivity!

 

Internationally Accepted Expertise In Standards Compliance: Our intimate involvement in the development of national and regional standards from around the world as well as International Standards from ISO & the IEC gives us the ability to help your team design products that meet the intent of requirements and not just the “letter”. This gives engineers and designers the maximum flexibility in meeting customer requirements and assures that the final product is approved in the shortest possible time. We achieve this goal through an extensive understanding of standards and direct contact with those who wrote the standards. Direct involvement in standards development also assures that we are aware of changes in requirements before they go into effect, allowing products to be designed to comply with them proactively rather than going through expensive redesigns after those changes become mandatory. We offer customized training for your teams in designing for compliance with standards. We also offer focused analyses of each design concept and develop an integrated plan for compliance. Finally, we can act as an interface and advocate between your organization and product certifiers.

 

Intimate knowledge of the Global Regulatory Environment: For some time, regulatory requirements around the world have been in flux as regulators drive toward global harmonization. This has created an environment where misunderstandings over what must be done in various markets (even within those countries) are common. These misunderstandings can result in delayed approvals and even illegal marketing of devices. We offer a direct connection inside of regulatory agencies in developed and developing markets assuring that you fully understand every option to achieving quick regulatory approvals (now including China!). Our involvement in global harmonization allows us to provide your organization with a clear picture of not only the current environment, but a view of what the future holds for regulation of medical devices through written analyses and customized regulatory training programs.

China UL CSA 601-1 Europe MDD FDA medical device regulation regulatory compliance litigation global standards risk management mike Schmidt 14971 essential performance EMC 60601-1-2  China UL CSA 601-1 Europe MDD FDA medical device regulation regulatory compliance litigation global standards risk management mike Schmidt 14971 essential performance EMC 60601-1-2  China UL CSA 601-1 Europe MDD FDA medical device regulation regulatory compliance litigation global standards risk management mike Schmidt 14971 essential performance EMC 60601-1-2  China UL CSA 601-1 Europe MDD FDA medical device 60601-1-6 Regulation standards risk management mike Schmidt 14971 essential performance EMC 60601-1-2  China UL CSA 601-1 Europe MDD FDA medical device regulation regulatory compliance litigation global standards risk management mike Schmidt 14971 essential performance EMC 60601-1-2 60601-1-6 IEC 60601-1 60601-1-6 training IEC 60601-1 training testing training IEC 60601-1 training usability process usability process usability process usability training third third third 3rd 3rd 3rd  edition edition edition 2005 2005 2005 new new new  standard standard standard standard