UpShot Engineering LLP

UpShot Engineering is a specialist in Medical Device End-to-End compliance management organization. We help medical device manufacturers in creating and maintaining technical documentations associated with developing and maintaining a medical device. We act as a product development consultant, work with you in every step of the product development cycle and support you to create the entire documentation to meet the expectations of global regulatory bodies. The strength of a medical device manufacturer is directly related to how well they control the device documentation. The modern-day product development faces several challenges, and one of the biggest challenge is regulatory compliance. It is crucial to prove compliance with standards and regulations when developing a product and stay up to date with the ever-changing regulatory landscape. We provide a global solution for product quality & safety by providing services for Design History File creation, EU MDR Technical Documentation creation, NMPA submissions, 510 (k) and PMA Submissions. Also, we create Risk management file, Protocol and Reports for Design verification/Validation, Gap assessment and remediation for USFDA, EUMDR, China NMPA etc., Partner with UpShot to Ensure Medical Device Safety for your customers, expedite medical device approval from regulatory bodies, and make medical device audits go smoothly that help products to market sooner. Upshot has proven track record of helping one of the largest medical device manufacturer in the world stay compliant with a business impact of $500M USD. Work carried out by UpShot was audited by Government Regulatory authorities with zero observations or NCs. We take care of End-to-End Compliance Management while you focus on your core R&D technology!