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.
DEFINE YOUR INTENDED USE STATEMENT HERE
Contact us for a FREE 30-minute confidential conversation regarding your quality assurance and regulatory affairs:
BOOK A FREE CONSULTATIONSERVICES
We are focused on two areas:
Quality Assurance
Ensure medical devices meet the required high standards
Regulatory Affairs
Guide clients to meet regulatory requirements
OUR PARTNERSHIPS
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.
If in doubt, get in touch to book a FREE consultation
BOOK A FREE CONSULTATIONSOME 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.
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.
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.
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.
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.
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.
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.
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.
