Understanding FDA QSR for Med Devices and Laser Product Performance Standards for Medical and Industrial Radiation Emitting Devices

1. Understanding the Basics (1 Hour)
• Description of Medical Devices (Leo)
1. Classifications of Medical Devices
2. Classifications of Radiation Emitting Devices
2. Quality System (QSIT) (5 Hours)
• The Quality System (Leo)
1. The Organizational Chart
2. Management Representative
3. Management Responsibilities
4. Internal and Supplier Audits
• Design Controls and Risk Analysis (Steve)
1. Design Controls - Design History File (DHF)
2. Design Input and Acceptance Criteria / Design Output / Verification and Validation Method
3. Design Review and Acceptance
4. Design Verification – Bench Testing etc.
5. Design Validation – Works as Intended – Clinical Study
6. Design Transfer
7. Design Changes
8. Risk Assessment based on ISO 14971
1. D.2: Energy Hazards and contributory factors
2. D.3: Biological hazards and contributory factors
3. D.4: Environmental hazards and contributory factors
4. D.5: Hazards resulting from incorrect output of energy and substances
5. D.6: Hazards relating to the use of the medical device and contributory factors
6. D.7: Inappropriate, inadequate or over-complicated user interface (man/machine communication)
7. D.8: Hazards arising from functional failure, maintenance and aging and contributory factors
• Design Change Controls (Steve)
1. Engineering Change Notice
2. Impact to Risk Assessment
3. Design Verification and Validation
4. Labeling Changes
• Document Controls and Electronic Signatures (Steve)
1. Document Change Control – Rev changes of existing documents
2. Document Distribution Matrix
3. Impact on Training
• Complaint Handling Procedures and Customer Feedback (Leo)
1. Definition of Complaints
2. Documentation and Control
3. Who Handles Complaints
4. Responsibilities and Authority
5. Investigations and Root Cause Determination
6. Adverse Event Reporting
7. Handling the Regulator
• Corrective Action and Preventative Actions (Leo)
1. Responsibilities of Initiator
2. Determining Root Cause and Risk Analysis
3. Timeliness
4. Corrective Action
5. How to determine effectiveness of corrective actions
6. Transactional Risk
• Closing and Discussion (30 minutes)

Welcome (15 Minutes)

1. QSIT Continued (3 Hours)
• Production & Process Controls (Steve & Leo)
1. Validate supplier (Laser) – Most likely offshore
2. Product ordering (lasers) specifications noted
3. Product receiving – AQL testing – mW output
4. Device Assembly – Verification check – mW output and device functionality
5. Labeling
6. Packaging and Shipping – Device Traceability
• Quality and Production
1. Product Realization Control
2. Responsibilities and Coordination of Quality & Production
2. Radiation Emitting Devices (4 Hours)
• Definitions and Classifications (Lasers) (Leo)
1. What’s the Problem
2. Regulations and Performance Standard Review
3. Reporting
4. Labeling
5. Quality Controls and Requirements
6. Manufacturer who utilize Laser Devices in Manufacturing of their Medical Devices.
7. What Other FDA Regulations Pertain to Radiation Emitting Devices
3. Conclusion/Wrap up session (30 minutes)

Leo J. Lagrotte is a Senior Regulatory Consultant for Quality Solutions & Support, LLC, a consulting practice offering auditing, training and advising to small, medium and large Medical Device and Radiation Emitting Device manufacturers as a follow-up to 20 plus years’ experience with the FDA and USDA. Mr. Lagrotte’s previous regulatory service was preceded by military service as a commissioned Officer in the US Army, and twenty plus years as a civilian owner/operator of retail food establishments including bakeries, restaurants and catering.

His experience with the FDA commenced as an investigator in Florida District/Tampa Resident Post in 2001 conducting inspections of predominately food processing establishments including all HACCP programs, LACF and Acidified Foods then advancing to Medical Devices in 2003 with the Level II Certified Medical Device Investigator (one of forty-four nationally) in 2005 and Southeast Regional Electro-Optics Specialist for Lasers and UV devices both with medical and industrial application in 2004. He also served on the Medical Device Inspection Cadre and conducted over thirty-five foreign inspections of Medical Device, Laser, and X-Ray manufacturers. During the course of his duties with FDA, Mr. Lagrotte conducted over 500 Establishment Inspections domestically.

Presently, Mr. Lagrotte’s focus is to assist the medical device and rad health community in meeting or exceeding compliance with all FDA regulations and Notified Bodies requirements for certifications, completing 510(k) and PMA submissions and responding to regulating officials as necessary on behalf of clients. At FDA and USDA he received a numerous national awards / recognition certificates for exemplary performance. In 2007, he was nominated by Florida District for the Patrick Pouzar Investigator of the Year Award for exceptional performance, integrity and reliability and the FDA Outstanding Service Award in 2011.

Stephen Inglese is a Founder and CEO of Quality Solutions and Support, LLC. Mr. Inglese began his Quality Systems career with Florida Power and Light (FPL) Company in South Florida. During his career with FPL, he was instrumental in being awarded the prestigious Quality - Deming Award, the first United States firm to challenge then win the award once only achieved by a firm located in Japan.

During that time, Mr. Inglese was placed in a position as a facilitator and was given the opportunity to study under the direction of Japanese Union of Electrical Scientists, then teaching those within various locations of FPL under the Quality Improvement Program. During his time with FPL, Mr. Inglese was also serving in the United States Air Force Reserve. There, as a flyer in a Combat Search and Rescue Unit, he was given the opportunity to assist in the dissemination of the Total Quality Management program to a group of 500 Airman. This quality program provided the tools and techniques to achieve a successful quality improvement process. He continued his quality carrier with the Tribune Company in South Florida as a system analyst in providing data to assist in improving circulation of the firm’s local newspaper.

Mr. Inglese then transitioned to ISO 13485 and the medical device industry. He successfully maintained the ISO / FDA quality system for several medical device manufactures in the medical laser industry. During this opportunity, he created design history files for new devices and technical files to assist in marketing the devices within the United States and off shore. He led the firm through successful implementation of the Quality System as required by FDA and foreign notified bodies, internal and supplier audits and management reviews.

Mr. Inglese founded Quality Solutions and Support, LLC in 2010 to assist firms in maintaining (or developing) their Quality System be it ISO, FDA or Medical Device Directives, Health Canada or other Notified Bodies globally. This includes establishment and maintenance of these firm’s design controls, audits (internal or vendor), technical files and 510(k)s.