About Us

MRG is a group of consultancy companies that provide Medical Device Manufacturers with the Regulatory support needed to ensure a high level
of accessibility in MENA region.
As one of the leading Regulatory Affairs consultancy and licensing firms, MRG is representing over 400 medical device manufacturers worldwide.
Working closely with various Regulatory Authorities all over MENA region like: Saudi Food and Drug Authority (SFDA), Egyptian Drug Authority (EDA), Ministry of Health & Prevention UAE (MoHAP) & Turkish Medicines and Medical Devices Agency (TITCK),etc.…

MRG is always pleased to be part of your success by assisting your business process in a high-level of Commitment through guiding and advising manufacturers on all the requirements pertaining to PRE and post-marketing requirements regarding all issues concerning medical devices, in-vitro diagnostic devices, contact lenses, laser surgical equipment and healthcare all over MENA Region.

Medical Regulations Gate - Medical Device consultancy company

To lead the market by ensuring that our clients are provided with the best consultation services to meet the regulatory compliance challenges and requirements for Medical devices, Cosmetics, health care and drug products in MENA Region.

As an experienced Regulatory Affairs and Medical Device consultancy company in MENA  Region, we offer precise regulatory Compliance solutions in Medical Device, Cosmetics, Health Care and Drug – Registration field, by fulfilling our client’s expectations through assisting and guiding them in every stage of their product registration, making sure they reach their targeted markets successfully.

 

The basic orientation of Medical Regulations Gate is to be recognized for quality in improving our commitment to deliver to our customers by providing quality consultation services for regulatory compliance. In support of our vision, the policy is to maintain a practical but comprehensive quality management system based on ISO 9001:2015. This will be central to the delivery of our commitment to customer satisfaction and continuous improvement.

We have established following systems/ procedures to support achievement of this policy:

  • Commitment from and involvement of Top Management to customer satisfaction and continuous improvement.
  • Responding promptly and accurately to customer enquiries and requests along with regular collection and monitoring of customer feedback.
  • Setting measurable quality objectives and setting defined responsibilities for their fulfillment.
  • Pursuing statutory and standard requirements.
  • Employee engagement at all levels of the organization along with their training and development initiatives.
  • Regular internal audit of our processes to check deviances from standards and management’s actions to address/ manage them.
  • Risk assessment and management.