- Introduction
As new treatment options, improved patient outcomes, and precision medicine are made possible, medical devices are becoming more and more important in today’s medical practice. More accurate and less invasive than traditional surgical methods, they play a growing role in the diagnosis and treatment of complicated medical diseases. The large number of medical devices on the market more than 2 million that are categorized into more than 7000 generic device groups make it challenging to determine which criteria apply to a particular medical device. To guarantee adherence to the pertinent regulations,it is essential to comprehend which guidelines are pertinent. This is very important, particularly for combo items like medication-driven medical devices.
Encompassing all facets of regulatory compliance requirements for the registration of devices and combination products in regulated and growing markets, our team of exceptionally skilled specialists offers a wide range of Medical Device Consulting services. Understanding the distinct procedures and intricate regulatory frameworks pertaining to medical devices, PharmReg Neoteric offers assistance and direction concerning every facet of medical device and diagnostic regulation, spanning from inception to after-sale, while staying abreast of regulatory modifications from pertinent authorities.
With our scientific and technical knowledge, the medical device regulatory compliance experts have helped clients register their devices and navigate the regulatory landscape by helping them set up and maintain a well-designed quality system that includes design controls to meet FDA and EMA requirements, including GMP and ISO 13485 certifications and standards, as appropriate.
When EU changed from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR), we assist customers in navigating the regulatory obstacles related to medical devices and diagnostics in competitive markets like the USA and EU. By using their extensive understanding of the regulatory environment to overcome regulatory obstacles, the medical device specialists at we can assist clients in navigating the regulatory process.
- Registration of establishment
- Premarket Notification 510(k), or Premarket Approval (PMA)
- Medical Device Listing
- Investigational Device Exemption (IDE)
- Medical Device Reporting (MDR)
- Quality System (QS) regulation
- Labeling requirements
- Import Licence or Registration of Medical Devices
- Manufacturing License
- Registration of an Innovative/New Medical Device
- Post approval changes
- ISO 13485 from DCGI’s notified agencies
