Michael Gomez

Michael Gomez is an experienced Quality Executive with thirty years of medical device experience in Therapeutics and Diagnostics including LDT’s. Prior to joining Simple HealthKit, Gomez was Head/Sr. Director of Global Quality Assurance at Predicine where he implemented and maintained the company’s global Quality Management System. He also held Senior Quality Executive positions at CareDX, Ripple LLC, and ArcherDX and is skilled in writing, implementing, and maintaining complete quality management systems compliant to ISO 13485 (EU QMS), title 21 CFR 820 (FDA QSR) and title 42 CFR 493.1200-1299 (CLIA Lab QMS).

Posts by Michael Gomez

How to Ensure Quality and Reliability for At-Home Lab Tests

Ensuring Quality is the best first step any company, especially startups, can take steps toward preparing for future changes to LDT regulations. Hire and lean on your quality expert to formalize documents to meet requirements, find gaps in best practices, and utilize internal audits to verify standards are being followed.

A Deep-dive Into Specialty Pharma

A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.

By PurpleLab

A Personalized Approach to Medication Nonadherence

At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.