DO YOU HAVE A MEDICAL DEVICE?

A medical device means any instrument, apparatus, appliance, software, implant, reagent, material, or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:

  • diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,
  • diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability,
  • investigation, replacement or modification of the anatomy or of a physiological or pathological process or state,
  • providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations

and which does not achieve its principal intended action by pharmacological, immunological, or metabolic means, in or on the human body, but which may be assisted in its function by such means.

The following products shall also be deemed to be medical devices:

  • devices for the control or support of conception;
  • products specifically intended for the cleaning, disinfection or sterilization of devices as referred to in Article 1(4) and of those referred to in the first paragraph of this point.
Contact us for a 30-minute confidential conversation regarding your quality assurance and regulatory affairs:
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SERVICES

We are focused on two areas:

Quality Assurance

Ensure medical devices meet the required high standards

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Regulatory Affairs

Guide clients to meet regulatory requirements

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ABOUT US

Adnan Ashfaq is a Quality, Regulatory & Validation Specialist with almost 20 years of experience in the Medical Device, Biotech, and Pharmaceutical industries. Adnan founded Simplimedica in 2011 and has since supported Medical device companies around the labyrinth of regulations and assisting them in flying through successful audits. He has worked with start-up companies and multinationals to develop new products since 1999. With regulations tightening, especially in Europe, Simplimedica enables and simplifies the compliance conundrum to ensure manufacturers reach their desired market and stay in the market.

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OUR TEMPLATES

Simplimedica templates have been reviewed, tried, and tested by our global clients. The templates will give you a head start on some of the documentation required for regulatory submissions.

TEMPLATE SHOP
If in doubt get in touch book a consultation
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SOME OF OUR CLIENTS

Simplimedica is a consultancy firm that believes in long-term partnerships. We support short-term, medium-term, and long-term project work for small medium-sized businesses as well as large corporations. You may have a shortage in skill or wish to outsource some work that may be more productive. Simplimedica has experience in a number of Pharmaceutical and Medical Device companies including some of those on our client list page.

CLIENT TESTIMONIALS

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. 

One of the best I know. 
Casey Sedgwick – Real Staffing
QA/RA Consultant- Medical Devices- North UK
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 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
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
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