Ensuring compliance with ISO 13485, EU MDR/IVDR, MDSAP, FDA, and other regulatory requirements is essential for bringing medical device, IVD, and combination products to market. A well-designed and maintained Quality Management System (QMS) reduces risks, streamlines processes and operational efficiency, and ensures product safety and effectiveness.
In the highly regulated MedTech industry, an effective QMS is a cornerstone for success. Companies face evolving regulatory requirements, complex documentation processes, and the challenge of integrating quality practices into daily operations.
Our consultants bring deep industry experience to help you establish a compliant and effective QMS that ensures compliance while supporting business efficiency.
Once your QMS is operational, our expert consultants are here to provide the specialist knowledge and hands-on support that is required to ensure you stay on top of your QMS activities whilst maintaining compliance.
Experience in quality management is crucial to avoid compliance gaps, audit failures, and inefficient systems that are not fit for purpose and slow down operations. With our expert guidance, your company can confidently establish and implement and maintain a QMS that not only meets regulatory requirements but also drives operational excellence and product quality.
Our consultants provide tailored support for:
Nelly Fransén
Staffan Thunell
Founding partner
BSc Economics and BA
Staffan has a long background in entrepreneurship within the life science industry. He has 20+ years experience from positions as Founder, Chairman, CEO and CFO within medical affairs consulting and small pharma. Previously Staffan worked in executive positions in big pharma and specialty pharma companies.
