Overview
We are a medical device consultancy company specialising in regulatory affairs, quality and compliance, Medaptivo is dedicated to supporting both emerging and established stakeholders within the medical device industry.
What Can We Do for You?
Medaptivo provides pre-market and post-market compliance solutions to all stakeholders within the MedTech sector – from well-established companies to forward-thinking start-ups.
Our capability covers a wide range of services, such as developing a regulatory strategy to gain market access, conducting a gap analysis against existing and new regulations, preparing audits for regulatory inspections, and developing technical and quality management system documentation.
Our expertise spans MDD and MDR regulations, quality system support for MDSAP, and ISO 13485 compliance across a diverse array of marketed and non-marketed medical devices.
How Are We Different?
We understand that manufacturers, their systems and devices vary in complexity, are at different stages of maturity, and that one size does not fit all. We therefore carefully tailor our regulatory solutions to each client’s individual needs. We offer support from simple enquiries and procedure updates to complete QMS development, medical device classification and technical documentation - including risk management, clinical evaluation and post-market surveillance.
Our Mission
Medaptivo’s mission is to enhance medical solutions and promote medical device safety and performance by working closely with companies worldwide to achieve compliance. Seamlessly and effectively.
We strive to customize our consultancy solutions to every company’s needs and help manufacturers adapt to the ever-changing regulatory landscape.