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Advena Add More Experience to Their Team

This month we welcome Richard Bassett to our team at Advena Limited., as our newest Senior Regulatory Consultant and QMS expert.

Some of you will already know Richard as he is joining us from a well-known major UK Notified Body where he has been a Client Manager and Lead Auditor. This has included working as a Lead Assessor for EN ISO 13485 and ISO 9001 systems covering all medical devices including IVD devices. Richard is a certified Auditor for almost all aspects of device CE marking, CMDCAS and overseas GMP requirements and has been closely involved in managing Notified Body audit teams. Richard is also an MDSAP lead auditor.

Specifically, Richard has been involved in management teams responsible for Quality Management Systems and Technical Files which included IVD Devices, Pregnancy Test Kits, Contact Lens Solutions, Eye Drops and Ear Drops plus the management and execution of associated supplier and internal audits.

This experience has involved working with risk management and the preparation of technical documentation including the classification conversion of cosmetic products to medical devices – an important issue under the new MDR and IVDR regulations.

Richard’s qualifications include an MSc in Structural Molecular Biology with a dissertation on the Structure and Function of Antibodies (specific to IVD research) and he is now completing a dissertation on Medical Device Regulation. These higher level qualifications complement an earlier BSc in Biomedical Science where study topics included biochemistry, medical microbiology, biotechnology, genetics, and immunology.

Richard’s background is specifically of note when considering the new classification systems for IVD devices in the EU.

Undoubtedly Richard has a wealth of experience to offer our existing and prospective clients alike and we welcome him to our expanding company. If like many of our clients you are looking for excellent experienced regulatory support please email Advena for a solution to meet your regulatory needs, please email: info@advenamedical.com

Another Advena Success!

Following an intense 3 day ISO13485 transition audit we are pleased to announce Advena Limited & Advena Medical Limited have been recommended for ISO13485:2016 certification.

This remarkable achievement is all the more impressive as it included a transfer from BSI to LRQA. Underpinning our ability to offer QMS consultancy to medical device manufacturers worldwide.

If you are looking to introduce a quality management system or to transition to ISO13485:2016 and need advice and consultancy please do contact us we have a team of experts ready to help!

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

Introducing the new look ACTIV – Web Based Quality Management System

This announcement was issued by the ACTIV providers, those who use this system should have now noticed the changes and the reports we have are very positive:

In October we’ll be refreshing Activ to give it a more modern look and feel. Along with the new styling, the main change you’ll notice is the improved Home screen, where we’ve simplified the way that Activ’s features are grouped and accessed into a new menu and added an action manager to help you get the most out of Activ.

The way that Activ’s existing features work is not changing and we’re confident that you will find the new menu self-explanatory and will enjoy using the new-look system.

So that you know what to expect, we’ve outlined the main changes below.

What’s new?

ACTIVHome Screen – we’ve simplified access to all parts of the system into a cleaner menu on the left of the screen and added a new feature: an at-a-glance action manager summarising actions assigned to you and your ‘To Do’ list.

My Details – manage all your personal information and Activ settings in one place, including login details and Notifications. The Notifications feature has been extended to include many more immediate alert options and we’ve also made it more configurable so you can select exactly what you do/do not wish to be alerted about.

Processes – now accessed from the menu and includes Process Reviews.

File Manager – all file storage and management features have been grouped together into one module. It houses all libraries including Records and Controlled Documents (Templates) plus File Reviews, Search and Recycle Bin.

Customers & Suppliers – all third party information is grouped together here. In addition to all your Companies information, it houses Contacts, Communications, Feedback and Supplier Assessments.

The switch was made on Monday 19th October and the system now has a more modern look and feel and we’re confident that you’ll enjoy using it. All your data will be secure and the way that Activ’s main features work is not changing. Along with the new styling, the main difference you’ll notice is the improved Home screen, where we’ve simplified the way that Activ’s features are grouped and accessed into a new menu and added an action manager to help you get even more out of Activ.

Contact Jacqueline Spittle (jacqueline.spittle@advenamedical.com) to answer any questions.

New Quality Management Requirements for OBL Manufacturers

Quality Management System

In relation to the Quality Management System [QMS] the OBL will be expected to maintain a QMS which covers the requirements as defined in the Medical Device Directive or IVD Directive as relevant. This does not mean that a fully compliant ISO13485 system must be in place although if this is the case it will simplify the process as ISO 13485 is the harmonized standard under both the MDD and IVDD for the QMS requirements.

The OBL documented quality system must cover the following areas as a minimum

  • Internal Audit,
  • Management Review,
  • Traceability,
  • Regulatory Requirements [e.g. Vigilance, Post Market Surveillance, Post Market Clinical Follow Up, informing regulatory authorities of vigilance issues],
  • Quality Objectives,
  • Complaints,
  • Order  processing and client communications
  • Document Control and Records
  • Organizational Structures and Responsibilities,
  • Control of the Manufacturing Process including any in-line or final performance testing and Non-Confirming Product,
  • Corrective and Preventive Action
  • Purchasing and Control of 3rd parties [including the OEM and other critical suppliers] must be included in the OBL quality system

These areas will be reviewed during your yearly assessment audits.

For those companies who OBL Class IIb or Class III medical devices, or List A / List B / Self Test IVD devices under Annex IV, it is mandatory to have Design Processes within your QMS. This does not have to cover design to first principles but as a minimum it must include how you as the legal manufacturer agree any changes to the design of the product.

As stated above this requirement cannot be delegated to the OEM it must also be under your control, so a formal procedure detailing how you manage design changes is required and a lack of such a procedure will result in a Major Non-Conformance.

Unannounced audits

Unannounced audits are required to be conducted at the place of manufacture of the devices and it is likely that these audits will be conducted at the premises of the OEM.

The costs will be charged to you as the legal manufacturer.

In your agreement with the OEM there will need to be a clause where the OEM allows these audits to take place without hindrance.  If an unannounced audit is refused by the OEM, a Major Non-Conformance will be raised which may lead to suspension of your certification and you will still be liable for any costs associated with the audit.

Discover more about Advena’s Medical Device Regulatory Consulting and Quality Management Services, or contact us on +44 (0) 1926 800 153 or via email to info@advenamedical.com

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