Regulatory Compliance for medical devices and IVDs
Regulatory compliance for medical devices and in vitro diagnostic (IVD) devices ensures that products meet safety, performance, and quality standards before and after entering the market.
Regulatory compliance is of utmost importance, and our QA/RA consultants can help navigate the complex landscape of regulations ensuring that all necessary standards are met at an appropriate level.
We offer you our global regulatory expertise and are always available for guidance, second opinions, and specialized consulting services.
Our expertise is grounded in a deep understanding of the regulatory frameworks that define the industry, including the EU’s Medical Device Regulation (MDR) 2017/745 and In Vitro Diagnostic Regulation (IVDR) 2017/746.
These regulations set rigorous requirements for clinical evidence, post-market surveillance, labeling, and traceability, demanding a proactive and systematic approach to compliance.
Regulatory compliance ensures that products meet safety, performance, and quality standards before entering the market, but not to be forgotten is the work to keep this in compliance also after the product has been released to the market.
Reduce risk and open for new markets
Conforming to regulations such as EU MDR, IVDR, and e.g. US FDA requirements reduce the risk of recalls or legal issues as well as a smoother approval pathway for market access. Strong adherence builds a reputation for reliability and opens doors to international markets by showing products align with global expectations. When compliance is embedded throughout a device’s lifecycle, organizations can address risks, adapt to evolving standards, and maintain a leading position in an increasingly complex environment.