OMEDtech attended the MedVentures Conference in Dallas, on October 10, 2012. MedVentures is an early-stage investment and education conference focusing on the rapidly growing medical technology sector. The medical technology sector includes medical devices and instruments, diagnostic equipment, medical therapeutic devices, medical monitoring equipment and other health-related products and services.

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 [...]

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 [...]

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 [...]

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 [...]