Helping You Ensuring Product Quality And Regulatory
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:
- General Electric
- Becton Dickinson
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:
To learn how I can help you with your specific needs, browse through the pages on this site ...
Then contact me to get started.