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Latest release: February 2017
Initial Certification Audit: Common Pitfalls for Medical Device Manufacturers
The certification audit is a though exercise and a major step for Medical Device Manufacturers looking to access a targeted market.
If you are looking to launch your company and your products or simply step into the world of the medical device industry, then be sure to thoughtfully plan and prepare your initial certification audit.
LNE/G-MED in this edition of the February newsletter, is discussing the most common pitfalls observed during a company’s first audit, pitfalls which may delay or simply prevent the company’s access to market.
Medical Device Single Audit Program
CE marking for Medical Devices
CE marking for IVD Devices
Quality Management System (QMS)