Medical devices have become ubiquitous and in order to reach a specific country, the companies must clear regulatory requirements to market their products either in the country of origin or across the globe. With medical device regulations becoming more stringent and lengthy, it is becoming all the more important for manufacturers to prove that the manufactured devices are safe to use and this requires a structured approach for medical device regulation. This is where Technomed Solutions specializes in providing seamless, end-to-end solutions to medical device manufacturers to achieve market readiness and develop an edge over their competitors.

It’s a pre-requisite to have a well-planned and thorough regulatory strategy right from the product development stage to meet the regulatory requirements. We will assist the medical device companies with a road map to formulate a better regulatory strategy.

We provide complete documentation for:

· EU regulations as per EU MDR 2017- Technical Documentation, General Safety and performance requirements, Essential principles, thorough Risk assessment, Risk report and Clinical Evaluation report and so on, for CE marking.

· Indian Regulations as per Indian Medical Device Rules: 2017- Device Master File, Site Master File, Essential Principles checklist and so on, for Medical Devices and IVDR.

· FDA submissions- 510 (K) submissions, Pre-submissions, denovo pathways and FDA device registration and listing.

After the completion of the documentation as per the suitable regulatory requirements, all documents are submitted for technical review and the queries raised from those submissions will be addressed in a timely fashion by Technomed solutions for device approval. 

We assist companies to roll out ISO 13485 compliance with documentation along with associated audits and training.

It is a systematic process to collect information of the medical device about its performance in the market. Technomed Solutions provides expert assistance in analyzing the information collected from the device to make the Post Market Surveillance Plan and Report (PMSR), Post Market Clinical Follow-up (PMCF) report and periodic safety update reports (PSUR) for devices. 

We assist in creating medical device labels and instructions for use, labelling review, training on ISO 13485 and getting test reports from NABL accredited labs for medical devices.