- Introduction
Medical devices are becoming increasingly essential in modern healthcare, driving advancements in treatment options, enhancing patient outcomes, and fostering the development of precision medicine. Offering greater accuracy and less invasiveness than traditional surgical methods, they play a crucial role in diagnosing and treating complex medical conditions. With over 2 million medical devices classified into more than 7,000 generic groups, identifying the specific regulatory criteria for each device can be a complex challenge. Understanding and adhering to the appropriate guidelines is critical, especially for combination products such as drug-integrated medical devices, to ensure regulatory compliance.
Our team of highly skilled specialists provides comprehensive Medical Device Consulting services, addressing all aspects of regulatory compliance for device and combination product registration in both established and emerging markets. With a thorough understanding of the unique processes and complex regulatory frameworks governing medical devices, PharmReg Neoteric offers expert guidance across every phase of medical device and diagnostic regulation—from development to post-market activities—while staying updated with changes from relevant regulatory authorities.
Leveraging our scientific and technical expertise, our regulatory compliance professionals have supported clients in registering their devices and navigating the regulatory landscape. We assist in developing and maintaining well-structured quality management systems, incorporating designcontrols to meet the stringent requirements of FDA and EMA, as well as compliance with GMP and ISO 13485 standards, as applicable.
When the EU transitioned from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR), we helped clients navigate the regulatory challenges associated with medical devices and diagnostics in competitive markets such as the USA and the EU. With their deep expertise in the regulatory landscape, our medical device specialists assist clients in overcoming regulatory hurdles and successfully managing the approval 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