0345 600 6975enquiries@qualitation.co.uk
  • F.A.Q
ISO Standards
SEARCH
Qualitation - ISO ConsultancyQualitation - ISO Consultancy
Qualitation – ISO Consultancy
The British Quality Centre
  • HOME
  • GROWTH & EFFICIENCY
  • ISO STANDARDS
    • Quality+
      • ISO 9001
      • ISO 14001
      • ISO 45001
    • Aviation ISO
      • AS 9100
      • AS 9110
      • AS 9120
    • Laboratory & Medical
      • CE Marking
      • ISO 17025
      • ISO 15189
      • ISO 13485
    • IT and Information Security
      • ISO 27001
      • Cyber Essentials
  • FREE TOOL
  • ABOUT
  • ARTICLES
  • CONTACT
Menu back  

CE Marking for Medical Devices

Make sure your product meets the legislative requirements of your industry.

CE Marking in the healthcare sector

CE Marking in the medical sector indicates that healthcare appliances – meet legislative requirements in full.

The certification that supports the CE Mark is ISO 13485. Like certification in other industries, it is based on ISO 9001 but adds sector-specific elements to prove compliance and provide certainty in the medical world.

Registered CE marks are a legal requirement for the sale of many medical devices within the European Union, but other countries outside the EU also formally recognise the marking system.

To place a CE mark on your product, you’ll need to:

  • Identify all applicable legislation
  • Check product-specific requirements
  • Test your product
  • Collate and keep all required technical documentation
  • Correctly place the CE mark on your product.
CE Marking, Qualitation, ISO Certification, Laboratory and Medical
Qualitation, ISO Certficiation

How ISO helps your medical device make a mark

CE compliance recognises that feedback and improvements will continuously be fed into systems, as well as facilitating harmonised regulatory requirements for medical devices.

As standards work in tandem with relevant regulations but are not in themselves written into law, CE mark requirements will only work as an effective process if manufacturers of medical equipment understand when it’s necessary to apply for and include a CE mark on their product.

Our Qualitators can help you understand the requirement for a CE mark and advise you about the process of achieving it. We assist with creation of registration documents, collaborate on technical information and requirements, and correct formatting of the application to save time and money. While we never assume we know more about your products than you do, our Qualitators have had a great deal of repeated experience gaining the CE Mark and the ISO 13485 standard for a wide range of medical devices.

 

The advantages of having ISO certification relating to CE marking include the fact your customers will recognise your compliance to a global industry standard. This has been particularly important within the EU, with companies operating across borders into other member states finding the process of approval for their appliances to be considerably shorter and technically less difficult than they might have been if CE certification did not exist.Going forwards, we do not anticipate Brexit changing this set up.

To find out more call: 0345 600 6975

Contact a Qualitator

Call: 0345 600 6975

Email: enquiries@qualitation.co.uk

Choose your ISO
  • ISO 9001
    12th September 2018
  • ISO Standards Support Key Business Priorities for 2018
    20th January 2018
  • How ISO Certification Influences Consumer Choice
    28th July 2017
  • Your Options on How to Get ISO 9001
    19th May 2017
  • ISO 17025 For Forensic Laboratories
    28th April 2017
  • ISO 13485, Medican Devices, Laboratory Competence and Calibration, Qualitation
    ISO 13485 Medical Devices
    14th August 2015
Case Studies
  • Anite Telecoms – 17025 GAP Analysis
    9th December 2015
  • Portsmouth Water – ISO17025
    27th August 2015
  • Qualitation, ISO Certficiation
    KP Acoustics – ISO17025
    20th August 2015
Qualitation
CONTACT

Telephone: 0345 600 6975
Reg. Office: 66 Elms Drive, Oxford, OX3 0NL
VAT 150 9855 91

Find us on:

LinkedinMail
Membership
  • bsi
  • tub
  • lrqa
  • cqi
  • bab
© 2015 Qualitation | Reg'd in England and Wales | No. 08265550
Qualitation is a trading name of Oxford Quality Centre Ltd | Privacy policy
We use cookies to give you the best online experience. By using our website you agree to our use of cookies in accordance with our cookie policy.