REGULATORY

Leverage our experience and excellent working relationships with FDA and EU regulatory agencies for your total product lifecycle. 

Regulatory authorizations

  • Strategizing, planning, technical writing, submitting to and corresponding with regulatory agencies

  • US, EU, Canada, and other global markets

  • 510(k), PMA, De Novo, CE Mark, HC License, and support for international registrations

  • Q-Submissions, IDE Applications

Product types

  • All regulatory classes (I, II (a/b), III, IV) 

  • All types of medical devices

  • Device – drug/biologic combination products

 

Consulting in US CFR Title 21, EU MDR, Canada MDR, and other international regulations

Due diligence for mergers and acquisitions

 

DEVELOPMENT

We coach our clients through design and development planning, product requirements definition, preclinical and clinical protocol development and execution, risk assessments, labeling content, and all aspects of design controls to ensure the data package for submission is right the first time. 

Product & Process Risk Management

  • Hazard analyses

  • FMEAs (Design, Use, Process)

  • Risk management plans, reports, files

 

Product Development Support

  • Design verification and validation planning

  • Design control and technical documentation

  • Liaison with biomaterial and pre-clinical test services and experts

  • Literature reviews and clinical evaluation reports 

  • Clinical trial design

 

QUALITY

Whether setting up your first quality system or making improvements to meet new standards or address audit findings, we provide solutions that don’t overburden your operations. 

Quality Systems & Compliance

  • Consulting, gap analyses, audits, and implementation

  • ISO 13485, MDSAP, and regulatory requirements for quality systems

  • Risk-based decision making throughout the product lifecycle

  • On-site support for FDA inspections and third-party audits

  • Warning letter remediation

 

POST MARKET

We specialize in post‐market surveillance systems

that provide continuous feedback about your

marketed products and ensure compliance with

post‐market reporting obligations.

Post-Market Surveillance

  • PMS and clinical evaluation plans

  • PMCF study design

  • Initial CER, CER updates, and PMS reports / PSURs

  • Complaint handling, vigilance, and regulatory reporting

  • Field action planning and implementation