HWREGULATORYSOLUTIONSLTD
What we offer
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EU Medical Device Regulatory SupportEU Medical device regulatory support
-Full technical documentation preparation and associated regulatory affairs support for all types of EU medical devices from self-certified Class I through to Class III.
-Support includes EU MDR Annex XVI devices without intended medical purpose, and Class III devices with ancilliary medicinal substance.
-Full support for transitioning existing legacy medical devices to the EU MDR 2017/745 for CE marking.
-Creation of medical device Quality Management Systems for EU MDR amd UK MDR 2002 under ISO 13485:2016, including setting up and maintaining medical device vigilance systems.
-Acting as PRRC under EU MDR Article 15.
-Advising on EU MDR transition timelines.
-Liaising with your Notified Body and the Competent Authority where required.
-Advising on regulatory strategy for medicine/ device/cosmetic/general product 'borderline' products.
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UK Medical Device Regulatory Support
-Full technical documentation preparation and associated regulatory affairs support for all types of UK medical devices from self-certified Class I through to Class III.
-Full regulatory support for UKCA marking under UK MDR 2002.
-Advising on UK MDR updates and timelines.
-Creation of medical device Quality Management Systems for EU MDR amd UK MDR 2002 under ISO 13485:2016, including setting up and maintaining medical device vigilance systems
-Acting as PRRC under EU MDR and UK RP for UK MDR 2002.
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EU Drug-Device Combination Products Regulatory SupportEU Pharmaceutical regulatory support
-Full regulatory support for Article 117 Notified Body Opinions required under the EU MDR for drug-device combination products authorised as medicinal products.
-Liaising with the Notified Body on for all aspects of your submissions
-Providing regulatory strategy advice
-Preparation of, and advising on, all content of the Article 117 Technical Documentastion for your combination products.
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UK Responsible Person for medical devicesEU QP for medical devices batch release.
Full UK Responsible Person support for non-UK manufacturers to enable continued UK distribution after Brexit.
Activities include:
-Advising on all aspects of UK medical device regulatory compliance.
-Registration of devices with the MHRA
-Liaising with the MHRA to resolve any product-related issues
-Full review of technical documentation for compliance with UK post-Brexit requirements
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Medical/Technical WritingMedical/technical writing
Preparation of medical and/or technical documents required to support your marketing authorisation or CE mark application.
Documents include:
-Clinical Evaluation Plans and Reports and Literature Reports for EU MDR and UK MDR
-Biological Evaluation Plans and Reports (ISO 10993)
-Post Market Surveillance Plans, PMCF Plans, PSURs and PMS Reports
-Advising on and preparation of Risk Management Files for compliance with ISO 14971:2019
-Creation of medical device design history files
-Preparation of medical device classification reports to support your regulatory strategy.
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UK Cosmetics Regulatory SupportEU Cosmetics regulatory support
Preparing your cosmetic products for Brexit from 1st January 2021, including:
-UK Responsible Person activities
-Advising on UK labelling. requirements.
-UK Cosmetic Product Notification activities.
-Preparation of full Product Information Files for UK compliance.
-Post-Brexit supply chain requirements.
-Advice on current 'permitted' ingredients for your EU and UK cosmetics.
-Medicines/cosmetics/devices borderlines advice.
HW Regulatory Solutions Ltd provides an individual regulatory service tailored to the needs of its customers.
Whatever your requirements, whether looking for a full regulatory package or assistance with discrete projects, HW Regulatory Solutions can help you realise your goals effectively, on time and on budget.
Our offices are based in North Somerset, near Bristol, conveniently situated near the M4 and M5 motorways, and mainline train services to London and the Midlands.
Dr Helen Woolford
