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Home
About
- About Simplimedica
- Internships
Services
Shop
- Book Consultation
- Templates
Insights
Contact

Home
About
- About Simplimedica
- Internships
Services
Shop
- Book Consultation
- Templates
Insights
Contact

Home
About
- About Simplimedica
- Internships
Services
Shop
- Book Consultation
- Templates
Insights
Contact

Medical Device Resources

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MDR – 2017/745

Regulation (EU) 2017/745 of The European Parliament and of The Council of 5 April 2017 on Medical Devices

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IVDR – 2017/746

Regulation (EU) 2017/746 of The European Parliament and of The Council of 5 April 2017 on In Vitro Diagnostic Medical Devices

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Key Articles & Annexes

Regulation (EU) 2017/746 of The European Parliament and of The Council of 5 April 2017 on In Vitro Diagnostic Medical Devices

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MDR & IVDR Guide

An introductory guide to the medical device regulation (MDR) and the in vitro diagnostic medical device regulation (IVDR)

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MDR & IVDR Implementation

Regulation (EU) 2017/746 of The European Parliament and of The Council of 5 April 2017 on In Vitro Diagnostic Medical Devices

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Infographic Guide Pack

This document highlights the key articles and annexes relevant to Medical Device Regulations

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Trusted by 100+ happy clients

Adnan has supported us in mapping out our regulatory requirements and setting up our QMS. As a start-up company, we needed someone who could be flexible and provide expert knowledge of the industry. Adnan took the time to understand the needs of our company and would often go beyond expectations, forwarding us relevant links and research to aid our efforts. His support and guidance has been invaluable to us. It has been a pleasure working with Adnan and I would happily do so in the future and recommend his services to others.

Bunsi Keshav

Technical Project Manager of Transformative AI

Adnan has been a name I’ve known on our medical device team for a while now. He is always looking for a new challenge and constantly being snapped up by a range of start-ups, SME’s and major players in the field. His knowledge in validation, quality, and regulatory is second to none and has worked for Real through key clients for the past few years now and the feedback is always amazing. He provides the best service and is always a pleasure to work with. His focus on the MDR and IVDR as of late had been invaluable and any client would be lucky to have Adnan on board.

Casey Sedgwick – Real Staffing

QA/RA Consultant- Medical Devices- North UK

Adnan has supported us in mapping out our regulatory requirements and setting up our QMS. As a start-up company, we needed someone who could be flexible and provide expert knowledge of the industry. Adnan took the time to understand the needs of our company and would often go beyond expectations, forwarding us relevant links and research to aid our efforts. His support and guidance has been invaluable to us. It has been a pleasure working with Adnan and I would happily do so in the future and recommend his services to others.

Bunsi Keshav

Technical Project Manager of Transformative AI

Adnan performed auditing of our company QMS. He was methodical and detail-oriented. His feedback and findings were useful in improving our QMS structure and implementation. He is an experienced quality management professional with a genuine desire to add value. We will recommend his services to organizations needing quality and regulatory input. OPSL.

Oleseun Olarewaju

Quality Manager for OPSL

Adnan recently supported us on our ISO13485 2016 transition through extensive gap analysis and appropriate updates to our QMS, which lead to a successful transition, he supported us as an Interim Quality Manager as well as our regulatory work. In addition he and his team have been involved in various aspects of facility and equipment validation and the implementation of a GMP QMS.

Faz Chawdhury

CEO of Nemaura Pharma

Lantor has used Adnan’s services for the generation of protocol and report documentation in projects relating to primary package validation and stability testing of medical devices. He has an excellent knowledge of the necessary regulatory requirements and always makes a point of being available for meetings and discussions via teleconference. He has proven to be very professional, reliable and resourceful.

Scott Bainbridge

Product Excellence Director for Lantor

Adnan at Simplimedica has been great at providing the required tools and information to effectively document the risk management activities of our medical device. He’s been a fountain of knowledge and resources throughout the process and has helped us create robust and presentable documents for our FDA and CE submissions. His expertise has significantly simplified the design control and risk management process and the route to achieving regulatory compliance overall.

Jason Peters

TruCryo Ltd

For over a decade, Simplimedica Ltd, led by Adnan, has provided us with expert guidance on ISO 13485, EU MDR compliance, and FDA regulations, assisting us in establishing an effective Quality Management System, and guiding us through regulatory activities from the outset, with the ability to translate complex regulatory language into actionable, understandable steps for our team.

He has always been proactive and committed to our success, making Simplimedica an ideal regulatory and quality partner for MedTech start-ups.

Alberto Casonato

CEO, Orthoscape Ltd

We extensively worked with Adnan on a major supplier transition project for ConvaTec, to our Company GA2 Medical Sdn Bhd. This involved advising on validations, risk management activities, and protocol and report preparations. Throughout, Adnan’s approach was systematic, adaptable, and professional and his technical knowledge of the regulatory requirements, and what that specifically meant for us and our internal procedures and activities, was very impressive. He always made himself available for discussions and advice which made the process of change and implementation straightforward for us, in a not-so straightforward, and often demanding, situation. In a challenging and changing medical device environment, you need the right people in your corner. Based on our experiences, we would strongly recommend Adnan as your Quality, Regulatory, and Validation Consultant. He will be in your corner.

Brent Armitage

Managing Director of GA2 Medical

Adnan and the team at Simplimedica have been integral to supporting our Quality Management Systems and CA/CE marking process since 2020. They provide exceptional expertise and knowledge of both the UKCA/CE landscape and medical devices, which they have tailored to understand and meet the needs of the products we are building. The team have helped us progress with developing the documentation required for our technical file submission. Their commitment to our progress, proactive approach, and collaborative way of working have been important to our mission and we recommend them to organisations seeking medical device consultancy.

Melanie Bradnam, PhD (she/her)

Centre and Research Commercialisation Manager
UK Dementia Research Institute | Care Research and Technology
Imperial College London

Let’s Simplify Your Compliance Journey

Whether you’re launching a new medical device or navigating complex regulatory requirements, our experts are here to guide you. Book a free 30-minute consultation and get clarity on your next steps.

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