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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

A New Addition to the Advena Team

 

This month we welcome Dr Andrew Whitton to our team at Advena Medical Ltd., as a Senior Regulatory Consultant.

Andrew brings a broad wealth of knowledge and experience in medical device regulatory having previously worked in a number of senior regulatory roles and with many devices including IVDs, combination products, cardiovascular and wound-care devices, across all stages of the device life-cycle such as supporting the development, initiation and running of clinical investigations, obtaining regulatory approvals and controlling PMS and vigilance activities.

His experience has involved device registrations across the globe, focusing on the EU and US where he has lead work on submissions of EU Technical Files and Design Dossiers as well as US 510(k)s, De Novos and a Pre-sub for a PMA.

Andrew also has been instrumental in instigating and maintaining numerous Quality Management Systems which he has taken through a range of successful audits including both scheduled and unannounced Notified Body audits as well as inspections from the US FDA, CFDA, ANVISA and the KFDA.

Clearly Andrew has a lot to offer our existing and prospective clients alike and we welcome him to our growing company. If you like many of our clients are looking for excellent experienced regulatory support please email Advena for a tailored solution to your regulatory needs; 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!

Using Distributors and Importers as an EC REP and Data Security.

Over the years we have expanded our comprehensive European Authorised Representative services to many non-EU manufacturers who have traditionally used EU importers and distributors for this role.  Now, and particularly with the new EU device regulations looming that require data sharing, perhaps the time may be now to ask the question;   “Can you trust your importer or distributor with your intellectual property”?

This is an especially critical issue for new and innovative technology. Advena already operates a best practice approach treating client data as confidential, to reinforce this we encourage the use of non-discloser agreements, whereas others such as distributors may not always act in the manufacturers best interests and therefore, may not be so diligent.

When a device manufacturer works with Advena all confidential documents, manuals, certificates, dossiers and project related files are only stored on our secure password protected server that is accessible only to employees who are subject to stringent confidential agreements.

Client confidential data would never be archived on laptop computers that could be lost or stolen.

The new medical device regulation (MDR) stipulates that the manufacturer shall in order to allow its Authorised Representative to fulfil its tasks ensure that the necessary documentation is permanently available. This will be very important in the future where EU Authorised Representatives will be legally required to be able to access manufacturer’s compliance data.

So the question is, do you really want your distributor or importer to have permanent access to your sensitive technical data?

If you currently use a distributor or importer as your EU Authorised Representative, this is a subject worth some serious consideration.

Brexit and the UK Medical Device Industry

There has been a lot of uncertainly about how Brexit is going to affect medical device manufacturers in the UK.

Here at Advena we track the UK political news closely and feel now that unless there is significant shift in Westminster a “hard” Brexit may be almost inevitable.

This is emphasised by the UK Notified Bodies silently assuring they have an EU base so they may continue certifications.

For our non-EU clients this is no problem, we will change AR address and registrations to our Malta office but for those based in the UK there could be little alternative than to assign an EU Authorised Representative (with an EU office, such as ourselves) for label references and any applicable registrations so the CE marking may continue.

For a UK manufacturer to have to contract with an Authorised Representative consultancy in mainland Europe, with all the currency and associated language issues, may seem like a bridge too far when viewed alongside all the other regulatory changes on the horizon.

However, we at Advena thought about this possible outcome almost 2 years ago and now, with our established and manned office in Malta, we are able to offer a smooth transition without changing our administration and English language communication base in the UK.

For any EU medical device manufacturers concerned about this possible impact they should contact us now so we can offer a “pre-mandate” ready for such an eventuality at 30% off our standard AR fees for the first year. No invoice would then be raised until political necessity arises and a swift change over to the Maltese address, and any accompanying registrations can be made.

Contact our team if you want to know more and stop worrying about Brexit!

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