Regulatory Affairs

At ARC Regulatory our primary goal is to deliver platinum-standard solutions for companies in the in vitro diagnostic medical device industry. By integrating our services and expertise at various stages throughout the product development life-cycle, we guide and support companies through the myriad global regulations to ensure that every project’s commercial and compliance objectives are achieved.

Our consultants have extensive knowledge and experience of the regulatory requirements for a vast range of in vitro diagnostic medical devices, gained from working on a wide range of industry projects and interfacing directly with global regulatory authorities. These relationships, established over many years, are instrumental in our successful delivery of your regulatory approvals.

Strategy Development

We will develop regulatory strategies that cover the entire product lifecycle, from product feasibility to obsolescence. We will ensure that your market launch requirements are aligned with your global marketing strategy, fulfilling business objectives. We have experience in the following areas:

  • Development of US submission strategies, including: 513(g) requests for information; Q-subs strategy including study risk determinations; Alignment on analytical & clinical validation strategy and protocol design; IDE submissions; 510(k); de Novo and PMA strategies.
  • CE-marking and international registration strategies
  • PMDA pre-consultation; Briefing document development and consultation planning for Japan, in collaboration with your MAH
  • TGA and Health Canada submission planning

Regulatory Submissions

  • We will work with your development teams throughout the development lifecycle and the implementation of your submission strategy, to ensure regulatory submission requirements are included in V&V planning from the earliest opportunity
  • We will write your submission in the appropriate format for the regulatory authorities, and submit on your behalf or support you in your own submission
  • Following submission, we will interface with the regulatory authorities on your behalf, and in combination with your development teams, address any requests for information so as to keep the review clock on track.

Quality Management

Certification of your Quality Management System to the internationally-recognised ISO 13485 Quality System standard provides a strong indication that your business is committed to product safety and effectiveness, the achievement of customer requirements and continuous improvement. In addition, for most device classes, a certified QMS is a necessary element of the conformity process.

ARC Regulatory will provide expertise and support for your organisation’s certification to one, or both, of these Quality Management System standards.

  • QMS development and implementation
  • QMS development, in compliance with 21 CFR Part 820 – the US Quality System Regulation
  • 2nd party audits to assess your organisation’s certification readiness, and to support you in co-hosting certification audits
  • We will also engage the Certification Bodies on your behalf, facilitate the proposal process and help you to focus your audit preparation efforts on the appropriate areas
  • We also provide outsourced 3rd party audit services to EU Notified Bodies