Regulatory Affairs & Quality Assurance
We are dedicated to ensuring that we fully meet all the legislative and code of practice requirements that are commensurate with the performance of a quality driven commercial medical devices organisation.
Medical Device Vigilance
The team ensure that all our products are both ISO9001 (2000) & 13485 (2003) compliant. As well as making sure that we are at one with any relevant medical device directive.
Additionally, if any issues are raised in respect of customer use of our products, then all investigations and correspondence are handled here.
We feel it important that all customers are confident in our commitment to compliance; therefore you can view and download our ISO certificates by clicking on the links below:
Regulatory Affairs
The Regulatory Affairs team ensures that all our products are registered on a UK & International basis in accordance with the legislation required in each specific region or country.
In the UK we comply with the requirements of Lloyds Quality Regulatory Assurance (LRQA), the Medical & Healthcare Products Regulatory Agency (MHRA) as well as European & International medical directives.
Wholesale Dealer's Licence
Kimal hold a Pharmaceutical Wholesale Dealer’s Licence. The Wholesale Dealers Licence permits us to store and distribute pharmacy-only-medicines (P) and prescription-only-medicines (POM). Our Licence Number is WL/14163, and was granted to us by MHRA.
All the controls and working practices required by the licensing authority have been defined and embodied within our Quality Management System (QMS). Our QMS is routinely audited to ensure we continue to comply with the requirements of our Wholesale Dealers Licence.
Manufacturer Dealers Licence
Kimal also hold a Manufacturer Dealers Licence
To discuss any of the matters relating to Regulatory Affairs & Quality Assurance, please email the Departmental Manager - Amanda Makemson
