CONSULTING SERVICES |
Welcome to Quality First International
a medical devices consultancy
Quality First International is a leading, global medical devices consultancy, with extensive insight and business know-how in the medical devices regulatory field. QFI is committed to solving your regulatory, technical and compliance challenges to enable your medical device to enter the global marketplace. With our technical expertise, accuracy and confidentiality we can help you be the first to market, reinforce the approval of your medical device, resolve any compliance issues and solve other problems encountered during the regulatory approval of your medical device.
Latest News...
21 April 2010
Changes to obligation concerning labelling of medical devices containing phthalates
We are alerting our clients about changes to obligation concerning labelling of medical devices containing phthalates. The obligation became Law on 21 March 2010, consequently all products Placed on the Market and Put into Service (ie, supplied from 21 March 2010) must comply otherwise it is an Offence. The restrictions concern devices or parts (components or constituents thereof) intended to administer and/or remove medicines, body liquids or other substances to or from the body, or devices intended for transport and storage of such body fluids or substances.
QFI can help to examine the biological safety risks of phthalate in a medical device, explore relevant intolerance and toxicity aspects and formulate the required documentation to support continued Placement of product on the market.
In the event of queries, or for an applicable form, please do not hesitate to contact the following:
USA: Tom Alexandris +1-770-656-5513
EU: Rachid Hattab +44-208-221-2361
13 April 2010
New requirements to register medical devices in Greece
We are alerting our clients about new requirements for registration of medical devices in Greece. The new regulations became law on 21 March 2010, meaning that any product not registered according to the new requirements will be proscribed, regardless of whether it bears the CE Marking of Conformity or whether it has been registered previously under old law.
QFI can commence the registration with the local authorities in Greece on your behalf speedily on receipt of your instruction.
In the event of queries, or for an applicable form, please do not hesitate to contact the following:
USA: Tom Alexandris +1-770-656-5513
EU: Rachid Hattab +44-208-221-2361
10 November 2009
10 November 2009
10 November 2009
21 October 2009
1 May 2009
17 April 2009
Deadline for re-registration of medical devices and IVDs in the UK is 31 May 2009
27 March 2009
Download a FREE white paper comparing the Medical Device Directive and the Toys Directive
16 February 2009
Download a FREE white paper on the transposition of Amending Directive 2007/47/EC
28 January 2009
19 January 2009
Extended deadline for registration of medical devices in Italy
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