At Stark Pharma, we offer end-to-end design and development services for medical devices—from early-stage prototyping to regulatory approval and production transfer. Our engineering and regulatory teams work hand-in-hand to create innovative, safe, and commercially viable medical devices that comply with global standards including ISO 13485, FDA QSR (21 CFR Part 820), and EU MDR.
Whether you're building a Class I device or developing a high-risk Class III solution, Stark Pharma ensures a seamless path from concept to market.
We begin with user need assessments, market research, and risk-benefit analysis to define the clinical problem and engineer the most suitable device solution. We evaluate feasibility from technical, regulatory, and commercial standpoints.
Our ISO 13485-certified processes incorporate rigorous design controls, including Design Inputs, Outputs, Verification, and Validation (V&V). We apply risk management per ISO 14971, with tools like FMEA and HACCP integrated into every phase.
We leverage CAD modeling, 3D printing, and virtual simulations to develop and iterate prototypes efficiently. This accelerates feedback loops while ensuring form, fit, and function.
Our engineers optimize device designs to ensure manufacturability, scalability, and cost-efficiency—reducing downstream rework and ensuring a smooth handoff to production and supply chain teams.
We prepare comprehensive design history files (DHFs), technical documentation, risk assessments, and usability engineering files required for FDA 510(k), PMA, and EU MDR CE Marking submissions.
We conduct usability studies and human factor validations per FDA and IEC 62366 standards to ensure user safety and interface clarity—especially for devices intended for layperson use.
+1 (732)760-5152
hr@starkpharma.com
