Medical Device Services
Medical devices are increasingly demonstrating their importance in modern medicine, helping to improve patient outcomes, offer new treatment options, and enable precision medicine. They are increasingly important in diagnosing and treating complex medical conditions, becoming more precise, and less invasive than traditional surgical procedures. However, it can be difficult to identify which guidelines are applicable to a specific medical device due to the vast number of medical devices available, which exceeds 2 million and is classified into over 7000 generic device groups. It is crucial to understand which guidelines are relevant to ensure compliance with the appropriate regulations. This is crucial especially for combination products such as drug-led medical devices.
With a team of highly proficient professionals, DDReg provides a comprehensive range of Medical Device Consulting services that encompass all aspects of regulatory compliance requirements for the registration of devices and combination products in regulated and emerging markets. Being aware of the unique processes and complex regulatory pathways for medical devices, DDReg provides support and guidance on all aspects of medical device and diagnostic regulation, from conception to post-market, while keeping updated with regulatory updates from relevant authorities.
The Medical device regulatory compliance experts at DDReg, with their scientific knowledge and technical expertise, has helped its customers for device registration and navigating through the regulatory environment by assisting them in establishing and maintaining a well-designed quality system that includes design controls to fulfil EMA and FDA requirements such as GMP and ISO 13485 certifications and standards accordingly.
To accommodate the unique needs of each company and product seeking FDA approval for medical devices, DDReg helps develop custom regulatory strategies. The Medical Device Consultants at DDReg have a deep understanding of the regulatory landscape and can create a roadmap that meets the requirements for target markets. Having the expertise to compile all necessary information into technical files, device master files, design dossiers, and design history files is crucial for speeding up device reviews and obtaining approvals.
DDReg helps clients overcome regulatory challenges associated with medical devices and diagnostics in stringent markets such as the USA and EU- especially following the transition of Medical Device Directive (MDD) to Medical Device Regulation (MDR) in the EU. The Medical Device experts at DDReg can guide clients through the regulatory process, leveraging their in-depth knowledge of the regulatory landscape to navigate regulatory hurdles.
DDReg’s Medical Device Regulatory Services 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,
Import Licence or Registration of Medical Devices,
Registration of an Innovative/New Medical Device,
Post approval changes,
ISO 13485 from DCGI’s notified agencies