Bringing a medical device to market means navigating complex regulations, technical requirements, and ongoing compliance obligations. At Taylored Consultancy Ltd, we cut through the confusion and provide clear, commercially focused regulatory support to help you launch with confidence. Whether you need help with technical documentation, product classification, or quality management systems, we ensure your device meets UK and EU regulations without unnecessary delays.
We compile and review your Technical File to ensure it meets all regulatory requirements, including design specifications, testing data, and risk management documentation.
We support risk assessments and management processes to help identify, document, and mitigate potential product risks in line with ISO 14971.
Supplier compliance is critical for medical devices. We assess your suppliers’ QMS performance to ensure regulatory and quality requirements are met.
If your device comes into contact with the body, it needs biocompatibility testing. We help you identify the right testing requirements and ensure results are documented correctly.
A CER is essential for demonstrating safety and performance. We help compile and review clinical data to support compliance with UK MDR and EU MDR.
We assist in generating and reviewing your GSPR to ensure your device meets all safety and performance requirements under the latest regulations.
Unsure how your product is classified? We determine the correct classification under UK MDR and EU MDR, ensuring you follow the right regulatory pathway.
Already have documentation but unsure if it meets compliance standards? We conduct a full regulatory gap analysis to identify any missing or incomplete requirements.
We conduct internal audits to ensure your QMS meets regulatory and certification requirements, preparing you for external inspections and audits.
Medical device regulations can be complex, but they don’t have to slow you down. We provide practical, strategic support to help you meet compliance requirements efficiently—so you can focus on getting your device to market.
Your device’s labeling must comply with strict UK and EU regulatory requirements. We review your labels to ensure all mandatory information is correct and compliant.
We handle medical device registrations in the UK and EU, ensuring your product is correctly listed before it enters the market.
If you’re a non-UK or non-EU manufacturer, you must appoint a UK Responsible Person(UKRP) or an EU Authorized Representative (EC-REP). We act as your RP, ensuring your device remains compliant and meets all market requirements.
We help develop and implement Quality Management Systems (QMS) that comply with ISO 13485 (specific to medical devices) and ISO 9001 (general quality management),setting you up for long-term compliance success.
Food supplement regulations can be a headache, but they don’t have to be. We make sure you’re covered, compliant, and ready to sell—without unnecessary delays or legal pitfalls.
Facing a Notified Body audit or regulatory inspection? We provide hands-on support to help you prepare, respond, and maintain compliance throughout the process.
We’ve helped brands navigate competitor challenges, supported companies under MHRA scrutiny, and stepped in when businesses needed urgent regulatory intervention to stay on the market.
We’re known for helping innovative brands push boundaries, working with businesses launching cutting-edge, first-of-their-kind products that challenge the status quo.
Our expertise covers everything from Product Information Files (PIFs), UK Responsible Person (UKRP) and EU Authorised Representative (EC- REP) services, safety assessments, labelling compliance, and ongoing regulatory maintenance.
Whether you need a one-off consultation or long-term strategic support, we tailor our approach to fit your needs, timelines, and budgets.
Looking for a regulatory partner who understands business? Let’s talk.
Bethany has a wealth of experience in medical devices and is always providing a fantastic service. Having worked with Bethany on and off over the years I can safely say I would trust her regulatory advice. Thank you Taylored & the team!
We have been working with Bethany for 3 months now and are very impressed! She is super orgainsed, very knowledgable and does it all with a smile! Would highly recommend.
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Amazing! Went over and above working longer hours communicating with suppliers and getting all the relevant info. Quick to find solutions and overall very helpful. Thank you!
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