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Seasoned Product Safety and Regulatory Compliance professional with 17+ years experience in standards compliance management IEC 60601 series of standards for Medical Electrical Equipment and systems. Demonstrated expertise in Design for Compliance Consulting, testing, certification, lab accreditation, lab scope expansion.Full spectrum outlook on the End product safety regulatory compliance landscape having held positions as Complaince testing service provider with CBTL/NRTL, internal CTF-3 & ASCA Lab, external consulting services as well as internal compliance expert, managing external Saftey and EMC compliance testing/certification with multiple providers. Particular Expertise in multifuntion monitoring equipment
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Principal Compliance Engineering LeaderHaemonetics Mar 2022 - PresentBoston, Ma, UsResponsible for End product standard compliance and certification management for full fleet Medical and IVD equipment. Transitioned all product lines reporting and ceritifcation to latest Product standard ahead of regional deadlines while maintaining backward compatible tracibility for regions, slower to adopt. Support regulatory staff with standards evidence and tracability for regional regultory filings -
Senior Product Safety EngineerPhilips Mar 2017 - Mar 2022Amsterdam, Noord-Holland, Nl60601 related Consultation, Testing and Certification (as CTF-3) focusing on Multi-function monitoring. Attained membership to ISO Standards writing committee TC121/SC1/JW6 for Respiratory Gas Monitors. Support lab accreditiations expansion for ULDAP and FDA ASCA. -
Senior Product Safety Engineer, MedicalBureau Veritas Consumer Products Services Feb 2014 - Mar 2017Kowloon, Hong Kong, HkTesting and Certification Services for IEC 60601-1 general, collateral and assorted IEC 60601-2-## particular standards. Particular focus on transition to 3rd edition and support incorporation of associated ISO 14971, Risk Management requirements as well as Home Healthcare Collateral requirements -
Sr. Project EngineerO'Brien Compliance Management Aug 2007 - Jan 2014Provide Medical device manufacturers consulting and testing for complaince with IEC 60601-1 and its associated collateral(-1-##) and particular(-2-##) standards for all types of medical devices at every stage from Concept through Compliance/Certification and Sustaining engineering.
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Mfr EngineeringBreakaway Imaging Jul 2005 - Jul 2007Design and integration for manufacturing many levels of components and sub-assemblies for multi-axis robotically controlled medical device. Working with contract manufactureers to pass off lower level assemblies to streamiline final sytem manufaturing. Support Product safety and EMC evalutions.
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R&DSeacoast Technologies 2002 - 2005
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ManufacturingGe Medical 2001 - 2002
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Manufacturing, PumpsMillipore 2000 - 2001
Chris Studley Skills
Frequently Asked Questions about Chris Studley
What company does Chris Studley work for?
Chris Studley works for Haemonetics
What is Chris Studley's role at the current company?
Chris Studley's current role is Principal Compliance Engineering Leader.
What is Chris Studley's email address?
Chris Studley's email address is ch****@****tas.com
What skills is Chris Studley known for?
Chris Studley has skills like Medical Devices, R&d, Testing, Manufacturing, Iso 14971, Iec 60601, Iso 13485, Quality System, Product Safety, Engineering, Design Control, Ce Marking.
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