News

2008

Qserve Consultancy B.V.

1 mei 2008, Purmerend

Qserve is on the move. The adress, telephone and fax number are changed.

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RAPS Horizons Conference & Exhibition

26–28 march 2008, RAPS

Qserve America Inc., Bill Greenrose, President will present at 2008 RAPS Horizons Conference & Exhibition, the Fairmont San Francisco . He presents in two sessions. Please vist the conference and for more information go to: www.raps.org/horizon2008

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2007

Biosensor technology for sciences and engineers

14-16 november 2007, Leuven, Belgium

Presentation; "Risk management of the biological safety and biostability of medical devices",
by Qserve; Dr. J. van Loon.
In this presentation an overview has given on the biological safety risks that needs to be evaluated during the design and development phase of a new device. Attention is paid to factors that might influence the biological safety of a device during production and toitems that lead to a re-evaluation of the biological
safety. A short introduction are given to some of the tests. 

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Medical Devices Directive revision

11 november 2007, European Commission of Medical Devices.

The Medical Devices Directive (MDD) 93/42/EG is revised on 2007-10-11. This directive shall be implemented in the national law on 2008-12-21.

There are some major changes for the manufacturers. Qserve consulting can advise to implement the changes ASAP before Competent Authorities or a Notified Bodies.Some changes are:

• Software for diagnostic and/or therapeutic purpose are now a active medical device.
  
• The following information cannot be treated as confidential; information about vigilance, certificates issued, modified, supplemented, suspended or withdrawn. Information on the registration of persons responsible for placing devices on the market.
  
• Classification rules, some changes are; Reclassify upwards from IIa to IIb disinfectants devices for disinfecting invasive medical devices. Stand alone software is considered to be an active medical device. Not only active medical devices but all medical devices for recording of X-ray diagnostic images are now in class IIa.
  
• Reference to machinery directive and personal protective equipment directive, devices shall also meet the essential health and safety requirements of these directives.
  
• Clinical evaluation is now necessary of all medical devices.
  
• Where a manufacturer who places a device on the market under his own name does not have a registered place of business in the European Union, he shall designate now a single authorised representative in the European Union.
  

For more information, about the new medical devices directive complete the info request form in the "Contact Us" section.

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Reclassification of joint replacements 

1 september 2007, Commission Directive

(2005/50/EC of 11 August 2005) reclassifying hip, knee and shoulder joint replacements comes into force in the Member States on 1 September 2007. This directive raises the classification of these devices from Class IIb (medium risk) to class III (high risk) .

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April 2007, MEDDEV

A new vigilance guideline has been issued by the European commission: MEDDEV 2.12-1 rev 5. These guideline describe the European system for the notification and evaluation of incidents involving medical devices, known as the Medical Device Vigilance System. The principal purpose of the Medical Device Vigilance System is to improve the protection of health and safety of patients.

For more information, about vigilance complete the info request form in the "Contact Us" section.

5 march 2007, GHTF

A new guidance document to make a STED for demonstrating conformity to the Essential Principles of Safety and Performance of Medical Devices (STED)

• Device Description & Product Specification
  
• Essential Principles checklist
  
• Risk Management
  
• Product Verification & Validation
  
• Design & Manufacturing information
  
• Labelling
  
• Declaration of Conformity 
  

For more information about conformity assessment complete the info request form in the "Contact Us" section.