Medical Devices are one of the most important sectors in healthcare. With advancing technologies and rapid innovations medical devices are one of the fastest growing industries. To accommodate with the rapid changes, medical device regulations are also very dynamic and changing very fast. The regulatory compliance is also growing as the various regulators are making the requirements more stringent. The industry as a whole is shifting from a reactive to a proactive approach across all aspects from research and development (R&D) all the way through to distribution. Medical device manufacturers are being required to submit more data on their processes and products than ever before. Thus, in today’s market, medical device companies need a proactive global regulatory strategy for rapid commercialization. We at RBridge understand your need and offer strategic guidance for India Registrations, CE Marking, ISO 13485 implementation, Clinical Investigation, and Approvals with various Regulatory Authorities.
We provide following services for Medical Devices.
India Regulatory Services
With the implementation of new Medical Device Rules 2017 (“MDR 2017”), Indian medical device regulations have become more streamlined with the global regulatory requirement. In tune with the global practice, the 2017 Rules have introduced a risked based classification system and classified medical devices in to 4 classes A, B, C and D.
CE Mark Consulting Services as per EU MDR 2017/745
The CE Mark on a product indicates that it complies with all the applicable requirements of the European Union. Obtaining the CE Mark allows your company to freely commercialize the product in the European Economic Area (EEA). To obtain CE mark for Medical devices, manufactures are now need to comply with the new Medical Device Regulations (MDR) 2017/745.
ISO 13485 Consulting
ISO 13485 Certification is the world’s most accepted and followed international Quality Management System (QMS) standard by the medical device industry. QMS is designed to help manufacturers comply with regulatory systems and understand what they need to do to place compliant devices on markets throughout the world. It is a collection of policies, processes, documented procedures,
A full Portfolio of Capabilities to deliver Measurable Results for clients Regulatory affairs Market intelligence and filing strategies. Regulatory filings at USA/ EU/ Emerging Markets Emerging Market Tender activities and support to participate thru capable distributors & facilitators
Rbridge Lifesciences Pvt Ltd