HELPING MEDICAL DEVICE COMPANIES ENSURE PRODUCT

QUALITY AND REGULATORY COMPLIANCE

Do you need to perform efficiently design verifications, test method validations, process validations, risk analyses, or remediate CAPAs and audit findings? If so, here’s how I can help:

My name is Alec Alpert, and I am an independent Quality Engineer and Consultant who has been helping medical device companies ensure product quality and regulatory compliance for more than three decades.

These leading corporations utilized my problem-solving skills:

• General Electric (Electronic Maternal-Infant Care systems).
• Philips (Electronic imaging systems - MRI, CT).
• Siemens (Electronic radiation oncology systems - Linear Accelerators).
• Abbott (Electronic Optical Coherence Tomography systems).
• Cook Medical (Catheters for minimally invasive procedures).
• Becton Dickinson (Electronic systems for diagnosis of infectious diseases).
• Medtronic (Electrosurgical generators for laparascopic surgical procedures).
• Zimmer-Biomet (Implantable orthopedic devices - knee, hip, shoulder).
• Terumo (Electronic hematology systems - blood collection and separation).
• Draeger (Electronic gas anesthesia systems).
• Endologix (Implantable systems for treating infrarenal abdominal aortic aneurysms).

SPECIALTIES

By leveraging my extensive experience in quality engineering and regulatory compliance, I can help you on the following projects:

• DESIGN CONTROL
• RISK MANAGEMENT
• TEST METHOD VALIDATION
• PRODUCTION SUPPORT
• PROCESS VALIDATION
• CAPA

EXPERTISE IN REGULATIONS AND STANDARDS

• 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.

PRACTICAL ADVICE

For practical advice on design V&V, process validation, risk management, CAPAs remediation, test method validation and more click here.