In the blog

  • FDA commissions review of the 510(k) process

    Very interested to read recently that the FDA has commissioned the US Institute of Medicine (IOM) to review the 510(k) process. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm183497.htm Whilst the review isn’t due to be complete until March 2011 I’ve already seen several articles from industry associations defending the current process. As part of the IOM there will be two public [...]

  • BSI acquires German Notified Body

    BSI has acquired German based Notified Body EUROCAT. EUROCAT is accredited for the certification of devices, IVD’s and active implantable’s and also offers product testing. See the official BSI press release here .

  • BSI adds to Fast Track service offering

    BSI has added a new accelerated programme for device manufacturers (CE-Dedicated Fast Track) looking to bring their product to market quickly.
    CE-Dedicated FastTrack offers reviews within 45 working days or less and does this by dedicating a reviewer to the project and by performing the review off-site. This is the 4th  such initiative BSI have introduced [...]

Scientific & Technical

Need help appraising technology?
Not sure what testing is required on your product?
Do you need to do regulatory, clinical and quality due diligence on a target company?
Do you need to outsource the development of your product to a specialist medical device group?

Within Emergo Group there is considerable industry experience gained running technical development projects or managing research and development groups.  Our fully flexible project management service has been utilised by a number of clients across a wide range of technology areas; from developers of class III cardiovascular devices to in vitro diagnostic test system manufacturers.

Our technical services offering prevents valuable time and management resource being directed away from core activities and ensures that the project proceeds accordingly.  Our service can be used as a bridge to recruitment, when projects are at a critical stage or in times of resource crunch where highly skilled individuals are only required for a short period.

Our technical group can assist with the following;

  • Independent technical project review
  • Project planning/management
  • Technical specification development
  • Preparation and implementation of integrated technical/regulatory project plans
  • Prototype manufacture outsourcing
  • Scale up manufacture and associated validation activities
  • Technology appraisal
  • Due dligence