Bill McLain, RAC is the President and Principal Consultant of Keystone Regulatory Services, a regulatory affairs and quality systems consulting firm for the medical device industry. Having held several positions of increasing responsibility exclusively with device manufacturers, Mr. McLain brings over 15 years of experience to your organization. His experience ranges from manufacturing and product development engineering to regulatory affairs and quality system management.
Mr. McLain brings a comprehensive, yet practical approach to your regulatory and quality system project. As he worked in both product development and regulatory affairs positions, he understands the challenges of getting a device to market and of creating a quality system that does not overburden business operations. Among his accomplishments are:
- Interfacing with product development groups to ensure that design inputs, and verification and validation testing met domestic and international regulators. expectations.
- Successfully preparing or supervising preparation of over 22 510(k) submissions and over 100 technical documentation files supporting CE Marking.
- Reducing average domestic 510(k) review time by 122 days.
- Hiring, training, developing and managing a four-person regulatory submissions group.
- Completing over 30 internal and supplier quality audits using the process approach.
- Maintaining a corporate quality system for a $450M medical device manufacturer to 21 CFR 820, ISO 9001:1994 and ISO 13485:1996 and achieving compliance status to regulators' expectations resulting in uninterrupted operations in all facilities.
- Managing a corporate internal and supplier auditing program including oversight of 10-member auditing team.
- Participating in Notified Body audits and FDA inspections.
- Developing a wire-reinforced, reduced-sized intra-aortic balloon catheter that provided adequate cardiac assist, yet allowed improved peripheral circulation.
- Providing training, oversight and mentoring for new product development engineers.
- Coordinating class II and III medical device developments among multiple suppliers, development and manufacturing facilities.
A member of RAPS and ASQ Biomedical Division, Mr. McLain is RAC Certified and holds a BS in Mechanical Engineering from Grove City College.