OUR REGULATORY STRATEGY SERVICES INCLUDE
Market Review and Regulatory Requirement Identification
We start with a thorough review of your target market and identify the applicable regulatory requirements, ensuring a solid foundation for your regulatory strategy.
Device Qualification and Equivalence Assessment
We assist in qualifying your equipment according to the identified requirements and address the equivalence of existing equipment, crucial for regulatory submissions.
Conformity Assessment Procedure Selection
Our team helps in selecting and complying with the appropriate conformity assessment procedures, which is vital for market access.
Intended Use Analysis
The culmination of our service is a comprehensive Regulatory Plan that outlines the methods for market entry, including recognizing applicable harmonized standards, MDCG guidelines, general safety and performance requirements, as well as necessary registrations.
BENEFITS OF A STRATEGIC REGULATORY APPROACH
Compliance Assurance
Ensures adherence to relevant laws and regulations, a prerequisite for market access.
Efficiency in Time-to-Market
A clear regulatory strategy can expedite the approval process, reducing the time to bring a product to market.
Risk Management
Helps in identifying and mitigating potential risks associated with the device.
WHY CHOOSE MDS FINLAND FOR REGULATORY STRATEGY?
In-Depth Expertise
Our team possesses deep knowledge and understanding of global regulatory requirements and processes.
Customized Solutions
We develop strategies that are not only regulatory compliant but also align with your business objectives and market aspirations.
Dynamic and Proactive Approach
With a deep understanding of the EU MDR and IVDR, we ensure that your QMS and technical files are not just compliant but are also aligned with best practices.
NAVIGATING GLOBAL REGULATORY LANDSCAPES
With MDS Finland, you gain a partner who not only understands the intricacies of regulatory requirements but also how they fit into the broader context of your business strategy. Our regulatory strategy services are essential in ensuring your medical device successfully navigates the regulatory pathways, from local markets to global scales.
