OUR REGULATORY STRATEGY SERVICES INCLUDE
Market Review and Regulatory Requirement Identification
We begin with a thorough review of your target market(s) and identify the applicable regulatory requirements—whether under the EU MDR, IVDR, or pathways to FDA approval—laying the groundwork for a clear and effective regulatory roadmap.
Device Qualification and Equivalence Assessment
We assist in qualifying your device in accordance with the applicable regulations and help determine equivalence to existing devices—critical for selecting the appropriate conformity assessment route or preparing for a 510(k) or DeNovo under the FDA.
Conformity Assessment Procedure Selection
We guide you in selecting and following the appropriate conformity assessment procedure based on your device’s classification, ensuring full compliance with MDR, IVDR, or FDA approval requirements.
Intended Use Analysis
Clarifying the intended use and claims of your device is vital, as it directly impacts classification, documentation, and reimbursement. Our team has analyzed over 60 devices in the past year alone and understands how intended use affects both EU and US regulatory pathways.
Regulatory Plan Development
We deliver a structured and comprehensive regulatory strategy that outlines the required steps for market access. This includes identifying applicable harmonized standards, MDCG guidelines, General Safety and Performance Requirements (GSPR), and registration obligations.
BENEFITS OF A STRATEGIC REGULATORY APPROACH
Compliance Assurance
A solid regulatory strategy ensures your device adheres to all relevant laws and standards under MDR, IVDR, and FDA approval frameworks – laying a clear path to market access.
Customized Solutions
With a well-defined roadmap, you reduce the risk of delays and rework, helping you reach the market faster and more cost-effectively.
Efficiency in Time-to-Market
Our strategy highlights regulatory risks early on – giving you the opportunity to mitigate them before they affect your timeline, budget, or compliance status.
WHY CHOOSE MDS FINLAND FOR REGULATORY STRATEGY?
In-Depth Expertise
Our team combines regulatory, clinical, and quality system expertise to develop strategies that are realistic, efficient, and tailored to your product and market needs.
Customized Solutions
Every device is different. We ensure your regulatory strategy is aligned with your business objectives and product lifecycle – whether you’re entering the EU under MDR/IVDR or pursuing FDA approval in the United States.
Dynamic and Proactive Approach
Regulations evolve constantly. We keep your strategy up to date, integrating new interpretations, guidance documents, and best practices so you stay compliant and competitive.
NAVIGATING GLOBAL REGULATORY LANDSCAPES
With MDS Finland, you gain a partner who not only understands the intricacies of medical device regulation but also how to connect compliance with commercial success. Our regulatory strategy services ensure your device is on the right path—whether in Europe, the U.S., or both—helping you make informed, confident, and timely decisions.
