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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.

check us out

our skills

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We create high-impact medical documentation including pharmaceutical and medical device regulatory writing, peer-reviewed publications, and patient communications.

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Writing is our passion
Writing

We provide a highly flexible service with a focus on supporting experimental design, data collection, and analysis.

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Research is our heritage
Research

We work with our clients to support the education of healthcare professionals to ensure that important messages and developments are delivered clearly and memorably.

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Education drives us
Education
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Offering flexible, time sensitive, cost effective solutions with a whole package approach.

#BrexitReady

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Your Project
Your Project

We specialise in organising conferences, advisory boards, networking events, and educational seminars.

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Meeting &
Events
Meetings & Events

We deliver targeted short films, manage social media, create print media, and produce slide decks.

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Creative & Digital
Creative & Digital

your project

 
 

Post

Brexit

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.

 

our

blog

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.

Films

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:

Published articles

Webinars

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

Pro bono

  • 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.

Final thoughts

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)

MMedEd

Scientific Director

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Our clients

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

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LONDON OFFICE
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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

BERLIN OFFICE
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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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Thanks for submitting!

 

steven.walker@stgmed.com

0207 836 7110