Reimbursement Services by MDS Finland

KEY ASPECTS OF OUR REIMBURSEMENT SERVICES Comprehensive Reimbursement Strategy Development We assist in developing a reimbursement strategy that aligns with your regulatory strategy. This includes demonstrating medical benefits and added value of your device, based on...

Regulatory Strategy Services by MDS Finland

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...

Person Responsible for Regulatory Compliance (PRRC)

OUR PRRC SERVICES INCLUDE Regulatory Expertise Our PRRCs have extensive experience and qualifications in regulatory affairs or quality management systems relating to medical devices. This expertise is essential in navigating the complex regulatory landscape of the EU....

Quality Management Systems: ISO 13485

OUR SERVICES INCLUDE Prefilled Document Templates We provide prefilled document templates for ISO 13485:2016, making the process more efficient. Customization of QMS Our team customizes the QMS to fit your specific requirements, ensuring compliance with both ISO 13485...