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ELECTRICAL SAFETY TESTING

It is obvious that test laboratories are getting totally bogged down with the testing to EN ISO 60601-1 3rd edition. We recently got a message from Intertek that they could not take on any more EN ISO 60601-1 3rd edition testing as the risk management phase was taking too long and they did not have enough people!

Any client who still has a problem on this we may be able to assist by doing the Risk Study and linking it, by check list, to 60601-1 requirements.

Enquire to john.adcock@advenamedical.com

 

MDD RECAST

The Notified Bodies around the world are preparing themselves for the new upcoming MDD regulations recast. The regulation was published on 26th September 2012 includes the new EU regulations on all medical devices. The final regulation is likely to be released in 2014.

The changes would reflect:

v  The new EU regulation structure and system

v  Conformity assessment procedures

v  Consequence for Notified Bodies, Authorised Representatives, Importers and Distributors

v  Requirements related to implementation, planning and documentation

v  Unique Device Identification (UDI)

v  CE marking procedure for medical devices

v  Management system in accordance with EN ISO 13485; Fundamental principles, Interface with International regulatory requirements, Differences to EN ISO 9001

v  Technical file for Medical  Devices; Overview of contents and structure

v  Clinical evaluation of Medical Devices; New regulations for Europe.

Advena will keep informing you about these summarizes with regular updated blogs.

Follow us on tweeter, blog and website for more information…

8 reasons why you should implement a Quality Management System

QMS can help your business to:

1) Achieve greater consistency in the activities involved in providing products or services.

2) Reduce expensive mistakes.

3) Increase efficiency by improving use of time and resources.

4) Improve customer satisfaction.

5) Market your business more effectively.

6) Exploit new market sectors and territories.

7) Manage growth more effectively by making it easier to integrate new employees.

8) Constantly improve your products, processes and systems.

Advena  implements and installs QMS using  www.isoinabox.co.uk Activ software.

ACTIV is a web-based QMS software package which can be accessed from any PC with internet access, around the world and enables you to electronically control all the above 8 reasons to comply with ISO 13485 standard.

If you are interested Advena would be more than happy to provide you with a log-in to our Advena ‘demo system’ which will provide you with an idea of what the system looks like as well as enabling you to experience some of its benefits.

Contact ela@advenamedical.com for more details.

 

European Commission provided guidance to EAAR members – Authorised Representatives

Manfred Koehler of the European Commission (in charge of European regulation for medical devices, SANCO Eurocrat and lawyer) joined the European Association of Authorised Representative (EAAR) on 26th September 2013.

He went straight to the point that the European Commission consider the regulatory responsibility of Authorised Representatives (AR) for self-certified medical devices to be on par with the regulatory responsibility of Notified Bodies for higher class EC certified devices. He said ARs were to be an important partner to police non-compliance of non-EU manufacturers and to be part of the EU “intelligence system.”

He stated that the obligations and tasks for ARs will be spelled out more clearly in the near future and they will become the goalkeeper to keep the EU free from non-compliant Class 1 and other self-certified devices

He recommended that the trade association (EAAR) should have a clear code of conduct, including mechanism to alert Competent Authorities about non-complaint manufacturers, fraudulent CE marking and unlawfully operating ARs. It was pointed out that the Notified Bodies are under the spotlight now, with Authorised Representatives to follow.

The trade association asked the EU Commission to be clear as to how ARs should police the compliance of client’s CE documentation but he was not prepared to make any specific comment except by stating the requirement were already in law and the AR must have prompt access to clients (manufacturers) technical documents (and their regular updates) and they must be sure (how?) that such document were compliant.

He was also clear that an AR must cancel contracts, and report non-complaint manufacturers immediately. (In the same way Notified Bodies remove certificates from non-complaint higher class device manufacturers.)

He finally stated that ARs will need to work alongside importers and distributors to assure all traceability information was always available and that a “Qualified Person” always releases product onto the EU market. In this respect ARs should have access to distributor / importer identity,

Action by Advena Ltd is planned to keep up to date with these impending requirements;

  • Assure that EU distribution contacts are part of the essential data to be available from clients. It may also be necessary to check if such distributors have suitable procedures to allow traceability.
  • To have a procedure to follow for reporting non-complaint manufacturers and promptly cancelling agreements.
  • Prepare to be audited and to be able to prove that we have access to all relevant documentation. (Netherlands already started)

Successful Innovation and Design for the Healthcare Market

John Adcock – Managing Director Advena Ltd will be speaking at the  ‘Medilink Design & Innovation Masterclass’ at Medilink West Midlands, Medical Technologies Innovation Centre, 4 Greenfield Crescent, Edgbaston, Birmingham, B15 3BE  on Wednesday 25th September – 9:30am – 4:00pm

John will be sharing his experience and providing good practical advice on

  • Regulatory considerations at the design stage – What standards need to be applied for?

Other discussions include:

  • How to make use of the end-users perspective to harness innovation
  • Market research for new product development – from developing research objectives      to using market research to gain quick wins
  • Protecting your innovation through patents, trademarks and registered design
  • Incorporating human factors into product design
  • Improving quality in the design process to reduce manufacturing errors
  • How to claim tax credits for R&D work

If you are interested in attending then please contact Lucy Watkins lucy@medilinkwm.co.uk

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