Navigating global medical device regulations can be complex, but Rook Quality Systems simplifies the process. Our expert team provides strategic guidance to help you achieve compliance with FDA, EU MDR, ISO 13485, MDSAP, Health Canada, and APAC regulatory requirements. 

From regulatory assessments to product registrations and market entry strategies, we ensure a smooth path to global approval, so you can focus on innovation while we handle compliance.

Our Global Regulatory Services

• Regulatory Assessment 
• 510(k) Preparation & Filing
• ISO 13485, CE Marking, MDSAP Certification
• Taiwan FDA Product Registration and QSD
• APAC Regulatory Support

The Value of RookQS Global Regulatory Support

• Expert Navigation of Global Regulations – 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 QMS.
• Accelerated Market Entry – RookQS’ seasoned team of quality and regulatory experts will help your company achieve efficient 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.
• Global Consulting Team – Choosing RookQS isn’t just selecting a consultancy; it’s investing in a partnership deeply rooted in your regulatory success and global market strategy. Together, we forge a collaboration that aligns with your ambitions, understanding your industry intricacies, regulatory landscapes, and market nuances worldwide.
• Certified Auditors – With a team of over a dozen Certified Auditors, we understand the expectation of notified bodies and external audits, how they interpret regulations being followed, and how closely guidance documents are being regarded.