Service
Regulatory Affairs for Medical Devices
Bringing a medical device to the market requires precise documentation, compliance with international regulatory standards, and efficient submission strategies. UpShot provides global regulatory affairs consulting to help manufacturers achieve fast-track approvals while minimising compliance risks.
Comprehensive Global Regulatory Submission Support
Our team ensures your medical devices comply with EU MDR, 510(k), PMA, NMPA, MHRA and CDSCO regulatory requirements. We specialise in technical documentation, regulatory impact analysis, and submission preparation, helping businesses avoid delays and simplify approvals.
Our Regulatory Affairs Services
Regulatory Submissions & Registrations
Assisting with international regulatory submissions including, but not limited to, 510(k), UKCA and EU MDR.
EU MDR & NMPA Submissions
Ensuring compliance with European and Chinese regulatory standards.
510(k) and PMA Submissions
Preparing FDA submissions for medical devices entering the US market.
Regulatory Impact Analysis
Identifying compliance challenges and providing practical solutions.
Regulatory Gap Assessment & Remediation
Reviewing DHF and technical file outsourcing for audit-ready documentation.
