Complete Regulatory Services for the Medical Device Industry


Demonstrated, Focused Experience

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 overwhelmed 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.

Contact Us▸


Principal 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.   Having held several positions of increasing responsibility in device design, management, and RA/QA, Mr. McLain brings over 25 years of experience to your organization. 

Mr. McLain brings 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.



Grove City College
Bachelor of Science in Mechanical Engineering, 1990

Professional Experience

Arrow International. 1990-2004
Product Development Engineer
Engineering Leader
RAQA Manager

Keystone Regulatory Services, LLC, 2004-Present
President and Principal Consultant

KEMA/DEKRA Certification, 2007-Present
Lead Auditor


Professional Activities

AAMI, Member
RAPS, Member
ASQ Biomedical Division, Past Chair
RABQSA, Certified Lead Auditor