We support every stage of medical device development to ensure safety, compliance, and efficient time-to-market. Our teams provide tailored assistance for startups and global companies alike, from development to certification. With 15 years of experience and innovations in packaging and manufacturing, we offer technical and regulatory guidance to help you bring your device to market successfully.
Innovation drives our work, and our R&D team transforms concepts into practical solutions tailored to your product, process, and method requirements. We support the design of medical devices and accessories, packaging design, development of specialized processes, and feasibility studies with technical guidance to finalize specifications.
Our experts support the development of validation strategies and the preparation of required documentation, helping reduce costs and accelerate market access. We provide guidance on validation files for critical processes, equipment and tool qualification following IQ, OQ, and PQ principles, process validation, cleanroom qualification, monitoring, risk management, and final sterile product validation.
We conduct extensive in-house testing and collaborate with certified partners to expand our capabilities.
Microbiological and surface residue testing covers bioburden, endotoxins, biocompatibility, THC, TOC, inorganic and particulate residues, sterility, and dose auditing in compliance with relevant ISO, ASTM, EU, and USP standards.
Our industrialization specialists guide projects from concept to production, ensuring technical feasibility and successful implementation. We provide support for assembly, cleaning, packaging, surface treatment, sterilization, and plastic injection processes, design manufacturing workflows, develop custom components and tools, define packaging and labeling according to requirements, and coordinate project planning with validation and qualification services.
We provide tailored guidance for developing your technical file in compliance with regulatory requirements. Our services include auditing quality management systems and manufacturing processes, implementing or updating QMS, establishing control methods, preparing or updating technical files for CE marking or 510(k) submissions, supporting certification audits and non-compliance responses, conducting regulatory analyses, and assisting with change management.
