Helping You Ensuring Product Quality And Regulatory

Compliance

Are you looking for an experienced, contract quality engineer/consultant to help you with design verification, risk management, resolution of CAPAs, process validation, or other aspects of quality assurance and regulatory compliance?

My name is Alec Alpert and I am a quality assurance engineer and consultant helping medical device companies ensure product quality and regulatory compliance.

Over the course of my career, I have worked at multinational medical device corporations, including:

  • Zimmer
  • Medtronic
  • Abbott
  • General Electric
  • Siemens
  • Philips
  • Terumo
  • Becton Dickinson
  • Draeger

What Medical Device standards do I know?

I have expertise in the following standards and regulations:

  • 21 CFR 820, Quality System Regulation
  • ISO 13485, Medical Devices - Quality Management Systems Requirements
  • ISO 14971, Application of Risk Management to Medical Devices
  • ISO 9001, Quality Management Systems Requirements
  • IEC 60601, General Requirements for Basic Safety and Essential Performance
  • IEC 62304, Medical Device Software - Software Life-Cycle Processes
  • EU MDR 2017/745, Regulation of the European Parliament and of the Council

What kind of assignments do I handle?

I specialize primarily in the following six areas of Quality Assurance for development and production of electronic medical devices:

Design Controls

Risk Management

Test Method Validation

Production Support

Process Validation

CAPA

To learn how I can help you with your specific needs, browse through the pages on this site ...
Then contact me to get started.