Profile

Username

skeverline

First Name

Steve

Last Name

Keverline

Title

Principal Advisor, Regulatory & Quality Assurance

Location

Cleveland, OH, USA

Professional Bio/Service Description

Over 25 years in the medical device industry, working across a broad range of medical devices, combination products, and organizations—from startups to global enterprises. Experienced in partnering with engineering, regulatory, clinical, quality, and operational teams to support new product development, regulatory strategy, design and manufacturing quality assurance, quality management systems, and regulatory compliance.

LinkedIn URL

http://www.linkedin.com/in/steve-keverline-5a261042

Languages

English

Expertise

Years of MedTech Experience

25

Licenses and Certifications

ISO 13485:2016 Lead Auditor (TPECS), ASQ CQA & SSBB

Areas of Expertise

Quality Assurance, Quality Control, Regulatory Affairs, Medical Device Testing, Good Manufacturing Practice (GMP), Product Development, Risk Management, Documentation & SOPs, Compliance & Auditing, Sterilization & Cleanroom Practices

Regions of Expertise

United States (US), European Union (EU), Canada, United Kingdom (UK)

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