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@haemonetics.com
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Chris Studley is listed as Principal Compliance Engineering Leader at Haemonetics, based in Nottingham, New Hampshire, United States. AeroLeads shows a work email signal at haemonetics.com and a matched LinkedIn profile for Chris Studley.
Chris Studley previously worked as Senior Product Safety Engineer at Philips and Senior Product Safety Engineer, Medical at Bureau Veritas Consumer Products Services.
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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
Listed skills include Medical Devices, R&D, Testing, Manufacturing, and 19 others.
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Boston, Ma, Us
Responsible 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
Amsterdam, Noord-Holland, Nl
60601 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.
Kowloon, Hong Kong, Hk
Testing 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
Provide 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.
Design 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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Chris Studley works for Haemonetics.
Chris Studley is listed as Principal Compliance Engineering Leader at Haemonetics.
AeroLeads has found 1 work email signal at @haemonetics.com for Chris Studley at Haemonetics.
Chris Studley is based in Nottingham, New Hampshire, United States while working with Haemonetics.
Chris Studley has worked for Haemonetics, Philips, Bureau Veritas Consumer Products Services, O'Brien Compliance Management, and Breakaway Imaging.
You can use AeroLeads to view verified contact signals for Chris Studley at Haemonetics, including work email, phone, and LinkedIn data when available.
Chris Studley is listed with skills including Medical Devices, R&D, Testing, Manufacturing, Iso 14971, Iec 60601, Iso 13485, and Quality System.
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