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.
Based on our experience with ISO 13485 and CE marking audits, most of these topics lead to major non-conformities ( NCs ) which need to be fixed prior to obtaining Certificates and that could therefore impact the certification timeframe.
Welcome to 2017. With the new year rolling in, here come new resolutions … or should we say new Regulations.
In June 2016, political agreements on the medical device and in vitro diagnostics medical device regulations were released and we are expecting these two new European regulations to be voted and published during the year 2017.
These two regulations are bringing numerous changes, so it is crucial for manufacturers, who will be impacted by these changes, to be ready.
For this first newsletter of the year, we will present 5 major changes for each regulation, based on the published political agreements.
LNE/G-MED NA will participate to RAPS 2017 Regulatory Convergence, at the Gaylord National Resort & Convention Center at National Harbor, MD.
The Regulatory Convergence is RAPS’s annual multi-day gathering of the global regulatory community. RAPS is the perfect opportunity for our clients to meet and discuss with some of our experts and specialists.
Join us on Wednesday, January 25th at 2:00 PM Eastern as LNE/G-MED North America Inc. will be hosting a free informative session on the MEDDEV 2.7.1 Rev 4: New Requirements and Changes for Clinical Evaluation Reports (CER)
2016 has brought its share of changes and announcements in the applicable regulations and standards. Many actors have already started to perform Gap analysis, build plan, and update their Quality Management System to implement or anticipate these changes.
For our last newsletter of the year, we compiled a summary of those changes, recent and upcoming.
Medical devices manufacturers are regularly asked about the safety of their products when introduced into an MRI scanner (Magnetic Resonance Imaging).
These questions usually come from competent authorities, notified bodies or medical teams. This is the subject of a regulatory strengthening and forms part of a growing number of standards (ISO 14630, ISO 14708, EN 45502, etc.).
The placing on the market of an implantable device is now impossible in some countries without prior information on the product safety during an MRI exam.
Therefore it becomes a major issue for MD manufacturers, especially with regard to implantable Medical Devices.
In June 2016, the new version (Rev.4) of MEDDEV 2.7.1 European guidance on the clinical evaluation of medical devices (MD) was published. It does not revolutionize the clinical evaluation approach but significantly increases the demands on the content of the file.
The new guidance is longer and more detailed, in order to provide numerous supporting examples and to clarify some terms. It does not introduce new requirements per say.
This newsletter presents the changes introduced by the guidance revision, applicable since June as there is no transitional period planned in the text.
Orange County Regulatory Affairs Discussion Group (OCRA) is inviting QA/RA management as well as key decision makers (CEO, CFO, and Internal Counsel) to discuss the business and financial implications of meeting the new regulations and engage with both seasoned Industry and Notified Body professionals to obtain valuable insights and information on how to proactively prepare for the transition to the new EU regulations for medical devices and IVDs.5.
This year, Jawad Mahdavi, Lead Auditor at LNE/G-MED North America will discuss the new MD regulation and its Implications for Medical Device manufacturers.