Helping Your Medical Product Succeed

At Peak Regulatory Consulting we are here to help you through your regulatory and quality management hurdles. With extensive experience in the medical device industry, we have the knowledge and resources to help your product exceed the requirements to get to market in the USA, EU and rest of world. 


Our Services

Traditionally, getting a product to the market means spending countless hours searching for independent regulators, paying per service and losing valuable time.

We combine all the services needed under one roof to ensure that you aren't jumping through unnecessary hoops and overspending. By providing a 360° view we make recommendations based on knowledge and experience to ensure that your product has everything needed to meet your goals. 

Here are some of the services we offer. 

For a full list, schedule a free 30 minute consultation.

Quality System Regulation

Set up certified QMS to ISO 13485 and 21 CFR 820.

Manage your QMS needs.

Audit support (3rd party and supplier audits).

FDA Filings

Submit a 510(k) application and obtain clearance.

Establishment registration assistance.

In-Vitro Diagnostics (IVD)

Submit a 510(k) application and obtain clearance.

Establishment registration assistance.

Preclinical Development

Supporting you through Sterilization, Packaging, 

Biocompatibility, Labeling, 

Validation, Verification Testing, Software Testing and

Electrical Safety Testing

CE Mark

Submit technical documentation for CE Mark application and obtain clearance.

Clinical Evaluation Reports

Author CEP, CER, PMS Plan and PMCF Plan

Ready to take your product to the next level?

We offer a free 30 minute consultation to evaluate your needs and to plan the next steps towards market clearance.