Medical Device Services

Medical devices are essential in contemporary healthcare, improving patient outcomes, offering new treatment choices, and facilitating precision medicine. Their importance is only expanding, particularly in diagnosing and treating complicated diseases that are more precise and less invasive. With more than 2 million medical devices grouped into more than 7,000 categories, the regulatory environment can be complex. Compliance with the right guidelines is critical, especially for combination products such as drug-led medical devices.

We at DDReg understand these challenges and provide a complete suite of Medical Device Services to make your regulatory journey easier. Our team of experts is skilled in medical device and diagnostic regulation, ensuring compliance at every step, from development to post-market.

Our Medical Device Services Portfolio Include:

•  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.