Join fellow MedTech members for this Member MeetUp to hear several engaging speakers discuss cutting-edge developments and opportunities for partnering, receive a tour of the facility and network with your peers. AGENDA 1:00 pm Member arrival and registration 1:30 pm Presentations Brian McIlroy, Commercial Healthcare Leader, GE Idea Works Joseph Grohowski, Founder and President, Praxis […]
Upcoming Event: Notified Body Expectations: Today, Tomorrow and into the Future
R&Q and Nerac invite you to join medical device professionals from GE Healthcare, MAQUET, Nerac and R&Q for a morning of informational sessions which will cover the regulatory changes which have driven the increasing demands and changing expectations of Notified Bodies, and what companies are doing to meet compliance.
Thursday, June 18, 2015
7:30am to 11:00am (EST)
Embassy Suites Waltham, Waltham, MA
Learn More.
Notified Body Audit Trends: Be in the Know!
By Donna Mitchell-Magaldi, Nerac Analyst
Originally Published: February 10, 2015
With Notified Bodies being periodically audited, it is important to understand that they will be reviewing your technical documentation with a much more critical approach. As the new regulatory framework is passed and implemented, further changes will increase Notified Body expectations. Auditors will continue to identify areas of concern and medical device manufacturers will need to stay vigilant regarding the findings of the Notified Body auditors in order to keep ahead of the expectations. Make sure you understand these trends!! Read More
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
Telemedicine: A Tool for Reducing the Cost of Delivering Medicine
By Roz Sweeney, Ph.D., Nerac Analyst
Originally Published: July 21, 2014
Global economic weakness beginning in 2008, along with an aging population, has intensified the need to reduce healthcare costs. There is a general consensus that the rate of increase in healthcare spending is not sustainable. Since 2009, the annual rate of healthcare spending increases have dropped in the United States; however, it is not clear if this is a temporary phenomenon, or if spending increases will resume to previous levels as the economy improves. Read More
Modest Impact on Personalized Medicine Expected from Recent SCOTUS Rulings
By Roz Sweeney, Ph.D. Nerac Analyst, The recent Supreme Court decision on the Association for Molecular Pathology v. Myriad Genetics case was the culmination of much litigation on the validity of patent protection for the genomic sequences of BRCA1 and BRCA2. Myriad Genetics’ patents on these two genes gave it the exclusive right to offer genetic […]
The Importance of Article Selection for Meeting the MedDev 2.7.1 Rev 3 Requirements
By Donna Mitchell-Magaldi, Nerac Analyst, On March 20, 2010, the revised Guideline; MedDev 2.7.1 Rev 3 Clinical Evaluation: A Guide for Manufacturers and Notified Bodies became a requirement for obtaining and maintaining a CE Mark for all classes of devices marketed in the European Union. An important component of the MedDev 2.7.1 Rev 3 is the […]
The Costs of Regulatory Noncompliance in the Medical Device Industry: Is it Worth the Gamble?
By Donna Mitchell-Magaldi, Nerac Analyst,
The global medical device market was valued at $350 billion dollars in 2012 (Mddonline.com, 2012).
Read more