BS EN ISO 14971:2012, Medical Device Risk Management, was released July 6, 2012. This revision changes only the EN version and not the ISO version. With regards to the EN version, more informative references have been added between the standard and the medical device directive (MDD 93/42/EEC). Some of these changes may present a challenge to medical device manufacturer’s that have CE marked products that they are marketing in Europe. OMEDtech offers Risk Management consulting services to help companies navigate the requirements of the standards.
Missed the FDA’s educational forum on Medical Device Reporting (MDR), Complaints, Recalls, Corrections and Removals? Check out this link for the handouts.
A new Mandatory Document (MD9) has been published. All ISO certification bodies issuing ISO 13485 certificates (under an IAF accreditation body) are required to apply MD9 to medical device manufacturer assessments starting July 2012. One requirement that may affect Manufacturer’s seeking ISO certification is an increase in the total duration of ISO 13485 audits. The details of this may be found in MD9 Annex D.
Automation of the Design Control process can help product development teams navigate mandatory FDA regulations for medical device design controls. By making this process easier and more efficient, innovative medical devices can get to market quicker thereby having a greater impact of people’s lives. Tietronix Software has developed a Medical Device Accelerator (MDA), a web based system that includes design control, document control, CAPA and MDR reporting features. The MDA can benefit start-up companies by offering a “cafeteria” style plan, where a company can choose only the processes required at their stage of development. Click on MDA to read the entire article in Medical Design Briefs.
The senate passed new legislation, June 26, that reauthorizes the latest version of the user fee bill. The bill introduces performance goals for the FDA. The bill nearly doubles the fees paid by medical device manufacturers. Medical device Manufacturers are required to pay fees for certain services that include 510(k) and PMA submissions and establishment registration. The bill seems to be supported by most of the industry as a positive step for shorter review times and encouraging product innovation. Read the entire article here.
Novocure, a solid tumor treatment company, has seen promising results in a phase III trial with it’s NovoTTF therapy. NovoTTF therapy is indicated for chemotherapy free treatment of recurrent glioblastoma multiforme (GBM) brain tumors. The results of the trial were comparable to active chemotherapy in extending overall survival, with minimal side effects and far better quality of life. Read the news release to find out more about NovoTTF-100 that is currently approved for marketing in the US and Europe.
When you’re frustrated with the regulatory process of getting a new medical device to market. This article is a great reminder of why it’s worth the effort. Watch what happens when children, who have received a cochlear implant, react to hearing for the first time.