Strategic Device Compliance Services has provided support to some of the Medical Device Industries leaders and innovators including:

 

· Atricure

· Cincinnati Sub Zero

· DEL Medical

· Ethicon Endo Surgery / Johnson & Johnson

· Ethicon Inc.

· US FDA

· Fisher & Paykel

· GE Healthcare

· Quest Diagnostics/The GMP Company

· Guangdong Medical Instrument Test Center (Chinese SFDA)

· Hill-Rom Company

· Ivy Biomedical

· Johnson & Johnson Consumer Products

· Korea Testing Laboratories (South Korea)

· Laerdal (Norway)

· Medix Engineering (Argentina)

· Noblitt & Rueland

· Philips Patient Monitoring

· Philips Imaging

· Progeny, Inc.

· Respironics

· Siemens

· UTE (French National Standards Organization)

· And many more….

 

Contact us today to see how we can provide support to your organization!

 

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Our Valued Clients

Mike W. Schmidt—Principal Consultant: EMAIL US / Phone: 513 236 5907

 

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