MedTech Regulatory Affairs
From regulatory strategy and technical documentation to global pre-market submissions and post-market surveillance — comprehensive regulatory affairs support for medical devices across every lifecycle stage.
Our QA Services
Four Pillars of Regulatory Affairs Support
Regulatory Strategy
Device classification, applicable standard identification, testing strategy, and Notified/Approved Body selection across EU, UK, US, Canada, Australia, and more
Technical File / Documentation
Creating, updating, and remediating technical files to the latest regulatory guidance — organised for swift review and reduced approval timelines
Pre-Market Submissions
Global dossier submissions — CE/UKCA conformity assessment, FDA eSTAR (510(k), PMA, De Novo), Health Canada MDL, and international registrations worldwide
Post-Market Activities
Post-market surveillance systems, regulatory change assessments, and ongoing lifecycle compliance to maintain certifications and minimise operational risk
Service Detail
Explore Each Service Area
Regulatory Strategy
Developing a robust regulatory strategy early in the product development process is crucial for efficiently advancing a medical device through its lifecycle. Our regulatory strategies can encompass the entire development and marketing journey of the device or focus on specific aspects such as device modifications or changing regulatory requirements.
Starting with defining the product's classification as a medical device in the target geographic market, determining applicable regulations and standards, and outlining the necessary testing strategies, a well-defined regulatory strategy sets a solid foundation for the project and helps avoid surprises down the road.
ReguLogix Consulting offers classification determinations for devices in any geographic location — whether reviewing classification rules in the EU, Canadian, or Australian medical device regulations or searching the US FDA device classification database — our determinations are backed by years of experience and provide clear justifications for the chosen classification.
Additionally, we can assist you in selecting Notified and Approved Bodies, providing information on which bodies offer CE or UKCA marking and identifying those with available capacity to accept new clients.
Technical File & Technical Documentation
Technical documentation encompasses all documents describing your device, and it is the manufacturer's responsibility to prepare for any device classification. This documentation should be managed within the Quality Management System (QMS) and regularly updated to ensure ongoing compliance throughout the product's lifecycle.
Producing clear and comprehensive technical documentation is essential for achieving expedited market access. Our approach follows the latest guidance to ensure all necessary information is included and organised for easy navigation, reducing review times and costs while facilitating faster approvals.
ReguLogix Consulting plays a pivotal role in creating, updating, and remedying your technical files to ensure continuous compliance and the safe placement of your device in the market.
Regulatory Pre-Market Submissions & Product Registrations
ReguLogix Consulting can assist you with various global pre-market submissions and product registrations, including:
- Pre-submission review meetings (Q-Subs, Pre-IDE, Pre-510(k), Submission Issue) and requests for designation (513(g)) with the FDA. We help plan and execute pre-submission meeting applications, ensuring accurate information is provided and relevant questions are posed to obtain desired feedback.
- International Dossier Submissions: Technical Files for UKCA/CE marking conformity assessment, eSTAR medical device submissions (510(k), PMA, De Novo, IDE) for FDA, Medical Device Licence (MDL) applications for Health Canada, and more.
- ReguLogix Consulting collaborates with in-country representatives to decipher regulatory agency requests and provide the most relevant information available. We have recent experience assisting with registrations in Australia, India, Brazil, the Middle East, South Korea, Israel, Malaysia, and more.
Regulatory Post-Market Activities
As part of your Quality Management System requirements, you may need to establish quality agreements with your suppliers and critical service providers.
Quality agreements are formal documents that define the responsibilities, expectations, and quality standards between a manufacturer and its suppliers. They are a key element of supply chain management under ISO 13485, EU MDR/IVDR, and FDA regulations.
ReguLogix Consulting has the expertise to assist with drafting quality agreements and ensuring all necessary elements are included to comply with current regulations. Our services include:
Global Coverage
EU, UK, US, Canada, Australia
& more
CE & UKCA Marking
Conformity assessment expertise
FDA eSTAR Submission
Multi-programme
compliance expertise
End-to-End Lifecycle
Supplier audits &
quality agreements
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