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...
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...
OUR INTERNAL AUDITING SERVICES Comprehensive QMS Audits We conduct detailed internal audits of your QMS to ensure compliance with international standards such as ISO 13485. Our audits evaluate all aspects of the QMS, including document control, risk management,...
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....
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...
