We are a medical writing, research, film and health education company based in London and Berlin.
Our aim is to support patients, healthcare professionals, academics, and industry through cost-effective communication services. As a MHRA-registered 'Responsible Person', we provide regulatory assistance to medical device companies in the UK post-Brexit.
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There are a range of changes for companies wishing to sell their medical device/IVD products in the UK post Brexit. To complicate matters, Northern Ireland is now regarded as part of the EU and here separate rules apply.
St Gilesmedical is offering a service to medical device manufactures based outside of the UK who wish to continue selling in the UK, or plan to introduce new devices here. In the first instance, they need a local ‘Responsible Person’ (RP) to register product details with the Medicines and Health products Regulatory Agency (MHRA) and manage correspondence. There is a timescale for registration depending on the degree of product risk e.g. by May 2021 in the case of a Class 3 device such as a heart valve and by December 2021 for an external limb splint. Where products involves chemicals or substances e.g. surgical lasers, manufactures may need to transfer their registration to UK-REACH.
For now, the CE Mark is accepted in the UK but needs to be replaced by the UKCA Mark before June 2023. For more risky products (Class 1s, 2a, 2b and 3) this may require review by a UK Notifiable Body (yet to be appointed). For UK manufactures wishing to trade in the EU, they will need both a UK-awarded UKCA and a EU-awarded CE Mark. This means extra cost and paperwork for all concerned.
The regulations are currently awaiting UK governmental approval and may change.
St Gilesmedical Ltd is now registered with the MHRA as a RP and can advise non-UK manufactures and manage all the necessary paperwork. EU companies may like the fact that we have a Berlin office, can work in both English and German and bring added value though our medical writing, research, film and education activities.
What a year!
Despite coronavirus restricting access to the London and Berlin offices, this year has been busier than ever. We have been involved in delivering diverse manuscripts, educational activities, conference reports, hands-on research, website building, and filmmaking. Several articles involve members of the team as authors. We are particularly proud of an upcoming opinion piece in the BMJ on historical lessons from previous pandemics, and a research article in Medical Writing on homeworking during lockdown.
Our 10 films for GP's and trainees covering recent NICE guidelines are being rolled out on the Univadis/Medscape platform to some acclaim. Topics include:
Our free educational webinars have attracted a wide audience and are still available to watch on ZOOM. These include:
Our Medium articles have been well received
Since March 2020, we have been supporting a group of over 20 charities, organisations and learned societies in their efforts to improve care during the pandemic. Check out our in-house website and films at www.whatmattersconversations.org.
After nearly 4-years, our research activities for the NHSE/Hospice UK end of life optimisation project (HOLISTIC Study) await a final data analysis.
Despite some predictions of a second wave of coronavirus. many of us were actually surprised when it did happen. Now we are again in the thick of it. As the vaccines start to be rolled out, we ask what mess the world will be left with once the pandemic is all but over. As always, crises bring opportunities. We hope our clients and colleagues stay well and emerge stronger. May 2021 bring new and exciting opportunities.
who we are
Our private company is primarily motivated by a desire to advance all aspects of healthcare.
Our team, led by Dr Steven Walker (Scientific Director) and Dr Christine Oesterling (Advisor), work across two locations in London and Berlin. This allows us to better manage resources, cope with periods of upscaling and avoid conflict. The core team are supported by a stellar host of associates that represent key areas of medicine.
Steven Walker MD
MMedSc (Clin Oncol)
and what they say
“I think you did an excellent job with the first 2 European Respiratory Society articles!” “Terrific job as always.”
Senior Managing Editor, Global Education Provider
Our London office is based in a building from 1733, the Vestry House, in the grounds of St Giles-in-the Fields Church on the border between Covent Garden and Soho, close to Oxford Street.
United Kingdom: Stgilesmedical Ltd.
Business address: The Vestry House, 60 St Giles High Street, London, WC2H 8LG.
Company registration Nr: 08849119.
VAT Nr: 211771142
By contrast, our Berlin office is in the Charlottenburg Innovations-Centrum, a modern glass and steel building that forms part of the Technische Universitat and is supported by the cities of Berlin and Brandenburg.
Germany: Stgilesmedical GmbH.
Business address: Charlottenburger Innovations-Centrum, Bismarckstraße 10-12,
10625 Berlin. Registry court: Amtgericht Charlottenburg, HRB Nr. 188939 B. USt-Id Nr. DE 313980662.
Geschäftsführer: Dr.med.Steven Walker.
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0207 836 7110