Regulatory / Quality

Handshake agreement

Regulatory: Whether it's pre-submission meetings, 510(k)s, De Novos, or PMAs, we customize regulatory strategies and are well versed in 483, and warning letter remediation should the need arise. 

Through an expansive network of strategic partners, we have international offices in the US, Australia, New Zealand, Germany, India, the UK, Latin America, and Asia, allowing us to function as your in-country Authorized Representative. 

  • Pre-Submission Meetings

  • 510(k) Submissions

  • De Novo Submissions

  • PMA Submissions

  • IDE Submissions

  • CE Technical File Submission

  • Technical File/DHF Remediation

  • Supplier Audits/Qualification

  • Notified Body Audit / FDA Investigation Support

Quality Assurance: A customizable ISO13485:2016-compliant Quality Management System (QMS), that has been rigorously reviewed by Notified Bodies and FDA and has successfully passed multiple audits. 

We can easily install, validate, and house Design History File (DHF) documentation in your new or refreshed QMS.

Plus, we often oversee design reviews and the approval of documents through the design process.

  • ISO 13485:2016 Compliance

  • Quality Plans

  • QMS Installation

  • Quality Agreements

  • Quality Engineering

Additional Services

Project Management

Leading your team or helping you build a new one, to design and develop your product to your exact specifications.

Risk Management

Aiding your risk management planning and analyses to support new or existing products.

Software Engineering

Developing software architecture, requirements, code, and testing for embedded systems of cloud-based platforms.