Our consultancy services cover a wide range of areas in the medical device industry. Here’s a brief overview of each:
Medical Device Act 737: Providing guidance on the requirements and standards that organizations need to comply with under this Act1.
International Standards: Assisting clients in maintaining international standards within their organizations.
Resources Management: Helping companies manage resources to maintain the best standards and quality within the regulatory framework of Act 737.
Establishment Advice: Advising establishments on matters under Act 737 and its subsidiary regulations, such as the registration of medical devices and GDPMD for the license of establishment.
Draft Guidance Document – Medical Devices Regulatory System V1:19/01/2005: Providing guidance on the regulatory system for medical devices.
Designation Of Conformity Assessment Body (CAB): Assisting in the designation of CABs.
Common Submission Dossier Template (CSDT) of IVD: Providing assistance with the CSDT of IVD.
Medical Device Product Grouping: Providing guidance on the grouping of medical devices, whether as a single unit, a family, an IVD test kit, a system, or a set.
Essential Principles of Safety and Performance for IVD: Providing information on the essential principles of safety and performance for in vitro diagnostic (IVD) medical devices.
Conformity Assessment for IVD Medical Devices: Assisting with the conformity assessment for IVD medical devices.
IVD Medical Device Classification System: Providing guidance on the classification system for IVD medical devices.
Establishments of Matter Under Act 737: Advising on matters related to establishments under Act 737.