Earl Singh
Attorney at Singh Advisors, Llc
Based in Minneapolis, United States
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Seniority
Manager
Department
Legal
Location
Minneapolis
Industry
Hospitals and Health Care
Company size
1 to 10
Contact information
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e•••••••@singhadvisors.com
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Background
About Earl Singh
Guide manufacturers in enterprise operational management. Experienced with FDA/EU compliance and good manufacturing practices in the design, development and commercialization of medical devices. Passionate about next generation smart devices and integration of software, micro-technologies, wireless transmissions, and information technology platforms. 32 years of experiences in law and medical device. Baseline Medical Device Compliance: • EU 2017 EU Medical Device Regulations (plus IVDR) • FDA 21 CFR Section 820 et. seq. • EU harmonization and conformity • Active/smart implants • Quality management systems • Device life cycle risks • Risk/benefit in medical devices • Q9 Quality and premarket risk assessment • Biological evaluation, biocompatibility, sterlization • Human factors/usability engineering • Clinical studies/data requirments • Good Manufacturing Practices • Technical compliance such as electromagnetic, low voltage, personal safety Information Technology Compliance: • Software as medical device • Interoperable medical devices • Network signal and interconnectivity • Software life cycle • Software design verification/validation • Device data systems, image, storage • Management of cybersecurity • Computerized devices/process guidance • Mobile device applications
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