By Ron Sills M.S., Nerac Analyst,
Originally Published: July 6th, 2015
This article describes how medical device manufacturers can and should protect their products and business interests through patent protection. This includes not only patent protection of their own intellectual property, but actively monitoring the industry to ensure there is no infringement on their intellectual property.
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Establishing State-of-the-art Compliance for Medical Devices
By Ron Sills, M.S., Nerac Analyst
Originally Published: June 22nd, 2015
The regulatory changes occurring in the EU have resulted in an increased scrutiny for many medical device manufacturers. In Nerac’s experience, notified bodies have shown an increased emphasis on the clinical evaluation reports which support the safety and performance of approved devices.
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Sample Report – Technical File Review
By Ron Sills, M.S., Nerac Analyst
Originally Published: April 7, 2014
A medical device company has requested that Nerac perform a pre-assessment audit of their debridement devices, which are a Class IIb product family, to assess compliance with the essential requirements of the Medical Devices Directive 93/42/EEC 2007, Annex IX, and with the company’s quality management system (QMS) certification per EN ISO 13485:2012.
This sample report demonstrates the findings of the review.
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Updating Technical Files – Is Your Company Ready for a Notified Body Audit?
Did you miss the recent webcast “Updating Technical Files – Is Your Company Ready for a Notified Body Audit?” You can listen to it here!
Preparing for a Notified Body Audit
By Ron Sills, M.S., Nerac Analyst,
Originally Published: October 3rd, 2014
Is your company ready for an audit by your notified body? Read more
Clinical Literature Evaluations via an Objective Third Party Reviewer: Maintaining Compliance with the EU Medical Directives and Beyond
By Ron Sills & Donna Mitchell-Magaldi, Nerac Analysts
Originally Published: September 26th, 2014
Our medical device team is at the Regulatory Affairs Professionals Society conference in Austin, TX and early reports are that the EU will be pushing hard on Notified Bodies to increase the demands on Medical Device Regulatory Affairs submissions. As a result, we feel that auditors will be much more critical in their inspection, so it is imperative that you keep your clinical literature evaluations and updates current.
We invite you to download our free white paper “Clinical Literature Evaluations via an Objective Third Party Reviewer: Maintaining Compliance with the EU Medical Directives and Beyond” to learn more about how we can help. Read more
Are Your Devices State-of-the-Art?
By Ron Sills, Nerac Analyst
Originally Published: September 29th, 2014
The European Union’s Council Directive 93/42/EEC concerning medical devices contains the essential requirements to be met by medical device manufacturers in order to market their products in the 28 member countries. Read more