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Avoid This Major Non-Conformity

A Major UK based Notified Body recently issued a major non-conformity to a medical device manufacturer in South Africa.

 

The auditor was not satisfied with the arrangements in place between the manufacturer and their EU Authorised Representative (EC Rep), in particular that their EC Rep was not a member of the European Association of Authorised Representatives (EAAR).

It should therefore come as a great comfort to our clients and prospective clients alike that Advena are not just a member of this respected organisation by are a founding member.

If this is an example of how Notified Bodies intend assessing a manufacturers EC Rep it should help make the decision process much simpler.

By choosing Advena as your EC Rep, you not only gain access to our regulatory experts, extensive experience and knowledgeable advice, you avoid this major non-conformity.

ISO 13485:2016 Success!

Advena Medical have chalked up a remarkable success, and at the first time of asking!

Having read and understood the requirements of this new edition of the QMS standard. Advena’s experts set about this tricky task providing carefully planned advice and guidance to our client, the result of which, after a 3 day audit by LRQA, one of the UK’s most respected Notified Bodies, was a glowing report and more importantly our client achieve the much converted certification it needed to move its business forward. This is sure to be the first of many ISO 13485:2016 success stories.

If you’re looking to transition to ISO 13485:2016 please contact us for more details and become part of a success story.

Email Advena: info@advenamedical.com

Gap Analysis to the new Medical Device Regulation EU 2017/745 (MDR)

This Regulation was released May 2017, the 3 years transitional clock is now ticking, manufacturers of medical devices have until May 2020 to be compliant. On first thought this appears to be plenty of time. However you should start your planning process now!

Manufacturers across the world are not only planning to transition to the MDR they are also transitioning to the new QMS standard ISO13485:2016, which must be completed in 2019. Notified Bodies are already quoting extended lead times due to shortages of staff and other operational issues, it makes sense therefore to commence your planning process, don’t get caught out!

With our team of experts Advena can help and guide you through the transition process from MDD to MDR.

Our comprehensive MDR gap analysis, reviewing your current technical file, will highlight gaps, deficiencies or non-compliances in your documentation and processes, this will be presented via our in-depth gap analysis report, with suggestions and recommendations on how to fix these in readiness for your first MDR audit.

For more details please contact our team: info@advenamedical.com

Fantastic Employment Opportunity at Advena

Job description

Role Title

Senior Regulatory Consultant – Medical Devices

Location

Office Based in Warwick, United Kingdom

Rewards

Competitive salary.

About Us

Advena is essentially two companies; Advena Limited and Advena Medical Limited, both based at our offices in Warwick, UK. Both companies are expanding medical device consultancy business, Advena Limited also has an office in Malta. As a group we specialise in supporting small to medium sized medical device manufacturers and start-ups, to achieve regulatory compliance and CE Mark their products.

Summary

This is an exciting time to join as a Senior Regulatory Consultant in this crucial role within our small team of regulatory associates, to primarily work on preparing technical documentation and files for submission for audit by Notified Bodies.

As a key member of this team you will in essence manage your own work-load while also providing support and guidance to the junior team members helping them gain valuable experience to grow and develop with Advena.

This exciting opportunity would allow you to use your regulatory expertise to help develop our worldwide client base, in particular in guiding our clients through the transition from MDD/IVD to MDR & IVDR.

Essential Job Functions

You may be involved in the following activities as part of your day to day responsibilities:

  • Preparing, reviewing and approving data elements for use in regulatory technical files in accordance with EU requirements for medical devices and IVD’s.
  • Providing on-going regulatory advice and guidance, in an expert capacity, to all clients and junior members of the team.
  • Liaising with external regulatory authorities to ensure approvals are obtained in line with project schedules.
  • Performing all activities in compliance with relevant Quality Systems standards and specifically with ISO 13485.
  • Comply with all company policy and procedures.

Requirements

  • Substantial regulatory experience with a medical devices background is essential.
  • You must have substantial experience in the compilation and review of Class I, IIa, IIb and III technical documentation, in addition it would be beneficial to have experience with 510k file compilation and submission to FDA.
  • You will be required to compile clinical data, post market information/data for writing up Clinical Evaluations in line with the requirements of the revised MDD Annex X, MEDDEV 2.7/1 Rev 4
  • Risk analysis & risk management activities to ISO 14971 and FDA
  • Implementation of various standards and directives relevant to compliance to EU Medical Device Directive 93/42/EC and ISO 13485
  • Comprehensive understanding and Implementation of ISO 13485, FDA 21 CFR Part 820, Canadian ISO 13485 into quality management systems from inception and to upgrade existing systems and knowledge of MDSAP.
  • Have good interpersonal and communication skills and be a team player.
  • Attention to detail is extremely important as is the ability to work in a fast paced exciting and deadline driven environment.

Applications

If you are currently engaged in the activities of a Senior Regulatory Consultant or are ready for a step up and can demonstrate you meet the criteria outlined here, we would love to hear from you.

Applications must be submitted by Friday 9th September 2017, for those selected for an initial interview, these are currently planned to be held week commencing the 25th September 2017.

Please note we are currently not accepting applications via agencies.

Job

Regulatory/QMS.

Primary Location

Warwick, United Kingdom.

Schedule

Full-time.

Product Liability Insurance: MDR / IVDR

Advena Ltd. have now identified an insurer who will accept the risks of product liability insurance in accordance with the new regulations, needless to say for Advena as an EU Authorised Representative the premiums will increase significantly, several thousands of pounds higher than previously.

The good news is we will be able to continue to offer our EU Authorised Representative service under the new regulations.

In addition the insurance provider we have identified is willing to discuss with our clients their own insurance provision, should any client be interested in exploring this option please email Advena in the first instance, so we can make the initial introduction.

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