- In April 2023, Parexel International Corporation expanded its global regulatory consulting services to support medical device and combination product developers navigating the increasingly complex requirements under the European Union Medical Device Regulation (EU MDR) and In Vitro Diagnostic Regulation (IVDR). This strategic enhancement reflects Parexel’s commitment to helping clients accelerate market access by leveraging deep regulatory expertise and global presence, particularly amid tightening European compliance landscapes
- In March 2023, ICON plc announced the launch of a new Regulatory Intelligence platform designed to assist medical device companies in managing evolving global regulations and submission strategies. This digital solution provides real-time access to regulatory updates, compliance timelines, and document templates, enabling streamlined preparation and approval processes. The innovation underscores ICON’s focus on integrating technology with regulatory consulting to drive efficiency and accuracy for its clients
- In March 2023, Freyr Solutions opened a new global regulatory services hub in the Asia-Pacific region, aimed at supporting medical device companies with end-to-end compliance for country-specific approvals. The new center enhances Freyr’s capacity to manage growing demand from emerging markets and reinforces its position as a leader in regulatory affairs outsourcing by offering scalable, regionally tailored solutions
- In February 2023, IQVIA announced a strategic partnership with a European-based medical device manufacturer to support regulatory dossier preparation and clinical evaluation reporting under EU MDR. This collaboration emphasizes IQVIA’s strength in delivering comprehensive, customized regulatory services and reflects a broader trend of manufacturers relying on outsourcing to manage MDR complexities and mitigate risk
- In January 2023, Medistri SA, a Switzerland-based medtech service provider, introduced an integrated regulatory affairs and quality management consulting solution for small and mid-sized device manufacturers. This offering is designed to simplify the pathway to compliance for start-ups and emerging firms, providing cost-effective support for CE marking, technical file preparation, and post-market surveillance. The move demonstrates the industry's growing focus on scalable, accessible outsourcing services tailored to companies with limited in-house regulatory resources.
