All Services Engineering & Architecture Medical Device Regulatory Expert $125/hr · Starting at $35 Provides medical device manufacturers expert guidance in meeting global medical device regulatory compliance such as, US FDA and CE Marking. Experience in developing ISO 13485, FDA QSR, cGMP, CMDCAS, MDSAP and ISO 9001 implementable procedures. Michael has both electronics/electrical engineering and business background whose combined experience in both areas span over 20 years. His specific experience in the medical device industry include; product agency certification, regulatory and medical device research & development. Device Regulatory and R&D Experience: Formal Training: Accomplishments & Memberships: NRTL and Notified Body Experience: BSI UL Intertek/ETL TUV America (contract) About $125/hr · Ongoing Download Resume Provides medical device manufacturers expert guidance in meeting global medical device regulatory compliance such as, US FDA and CE Marking. Experience in developing ISO 13485, FDA QSR, cGMP, CMDCAS, MDSAP and ISO 9001 implementable procedures. Michael has both electronics/electrical engineering and business background whose combined experience in both areas span over 20 years. His specific experience in the medical device industry include; product agency certification, regulatory and medical device research & development. Device Regulatory and R&D Experience: Formal Training: Accomplishments & Memberships: NRTL and Notified Body Experience: BSI UL Intertek/ETL TUV America (contract) Skills & Expertise Iso 13485ISO 9001MedicalMedical Device 1 Reviews Amrit 13 says, Very knowledgeable in his field. Shares his own opinions and experiences to to better help with the project and make sure we are on the right path. for LED alternative for CO2 laser devices on Aug 06, 2018