Our Approach
We work to help you clearly communicated with your regulatory stakeholders. Many organizations that struggle with regulatory agencies simply haven't communicated clearly.
Your regulatory submission and Quality Management System tells your story. If they're too simple, they won't support and sustain your organization and your regulatory stakeholders will doubt your product and your organization's ability to support it. If your Quality Management System is too complex, you'll be burdened with unnecessary, self-imposed rules. You'll be overwhelmed.
Keystone Regulatory Services helps you achieve the balance between meeting regulatory obligations and keeping your organization lean and effective. We help you focus on demonstrating your product is safe and effective and maintaining operations under control
Get in touch
Keystone Regulatory Services, LLC knows that finding the right regulatory consultant is a choice not to be taken lightly. Please contact us so we can understand your needs and goals and so you can get to know us.
Principal Consultant
Sr. Quality and Regulatory Consultant
William McLain
Bill McLain is the President and Principal Consultant of Keystone Regulatory Services and has worked in the medical device industry his whole career. Bill has held several positions of increasing responsibility in device design, management, and RA/QA, and brings over 30 years of experience to your organization.
Bill offers a comprehensive, yet practical approach to your regulatory and quality system project. Having worked in both product development and regulatory affairs positions, he understands the challenges of delivering a device to market and of creating a quality system that does not overburden business operations.
Professional Experience
Arrow International. 1990-2004
Product Development Engineer
Engineering Leader
RA/QA Manager
Keystone Regulatory Services, LLC, 2004-Present
President and Principal Consultant
DEKRA Certification, 2007-Present
Lead Auditor
Education
Grove City College
Bachelor of Science in Mechanical Engineering, 1990
Professional Activities
AAMI, Member
RAPS, Member
ASQ Biomedical Division, Past Chair
RABQSA, Certified Lead Auditor
Rob McLain
Rob McLain joined Keystone Regulatory Services in January 2023 and, like Bill, has worked in the medical device industry his whole career. Rob has filled high-level quality and regulatory positions with recent focus on EU MDR (2017/745) transition and implementation, audit management, and electronic QMS implementation.
Professional Experience
Uromedica, Inc. 2016-2023
Senior Quality and Regulatory Engineer
QMS Management Representative
Keystone Regulatory Services, LLC, 2023-Present
Sr. Quality and Regulatory Consultant
Education
Grove City College
Bachelor of Science in Mechanical Engineering, 2016
Professional Activities
RAPS, Member
TPECS, Certified Internal Auditor