skip to Main Content
International Regulatory support

RookQS can provide international regulatory support to help expand the reach of your device. We have helped dozens of medical device companies grow their sales internationally through both quality and regulatory support. 

RookQS’ seasoned, robust team of quality and regulatory experts will help your company achieve international device approval in all major medical device markets, including United States, Europe, U.K, Brazil, Canada, Japan, Australia- and any other markets of interest- through on-site audit support and regulatory communication.  

By virtue of working in so many different markets, RookQS fully understands complex international regulations and when and how they overlap. We work with each of our clients in developing customized and in-depth regulatory strategies that leverage your current quality management system. We also assist with conducting and monitoring the implementation of your revised quality management system, training your employees, and on-going compliance and maintenance of your QMS.  

Sustaining regulatory and quality compliance across multiple markets is demanding, while also submitting to regular quality system audits. The Medical Device Single Audit Program (MDSAP) allows an MDSAP-recognized auditing organization to conduct a single regulatory audit of a medical device manufacturer that satisfies the relevant requirements of the regulatory authorities participating in the program. International partners that are currently participating in MDSAP include TGA Australia, Brazil, Health Canada, Japan, and the US. RookQS offers on-site audit preparation, training, and mock audits for both MDSAP and ISO 13485.  

With a dozen certified auditors as part of our team, we understand what notified bodies and external auditors are looking for, how they interpret the regulations being followed, and how closely guidance documents are being regarded. RookQS assists in creating your documentation, gap analysis, and responding to notified bodies. With the US FDA intending to harmonize the current U.S. Quality System Requirements with the ISO 13485 standard, the regulatory landscape is evolving towards a risk-based quality system. Some markets recognize certification to ISO 13485, whereas others require compliance to country-specific requirements. 

No matter where you plan to market your products, RookQS can help establish a QMS that meets the specific requirements of all the countries in which you intend to sell your product.

Related Resources

How To Prepare For Your First ISO Audit

Overview of ISO 13485:2016 ISO 13485:2016 is the industry standard for quality management systems for medical devices. Medical device specification developers, manufacturers, and distributors seek certification to ISO 13485:2016 for many reasons. Whether your organization…

READ MORE

What Should (and Shouldn’t) Go In a Technical File for MDR?

European regulations require manufacturers to create and maintain a technical file as a prerequisite to submitting a Declaration of Conformity, allowing products to be CE marked. If you’re like a lot of med device companies…

READ MORE

COVID-19 EUA and Enforcement Policy Transition Plans

In December of 2021, the FDA issued two draft guidance documents for transition plans for medical devices that were issued Emergency Use Authorizations (EUAs) and for devices that fall within enforcement policies issued during the…

READ MORE
Related Tools & Templates
Subscribe to our Newsletter
Join our mailing list for the latest Rook events, thought leadership, and more.
Back To Top