Pennine Healthcare are a registered medical device manufacturer, authorised by the UK regulatory body, the Medicines and Healthcare Products Regulatory Agency (MHRA), to manufacture single use disposable medical devices and procedure packs. We are in compliance with the Medical Devices Regulation (EU) 2017/745. Our Notified Body is the British Standards Institute (BSI).
We maintain compliance measures ensuring documentation, procedures, plant and equipment, staff protocols and training policies are subject to regular internal and external audit in accordance with the Quality Assurance Standard ISO 13485.
Pennine’s quality management system fully controls all aspects of our process management and focuses on our commitment to quality at the highest level which is shown in our procedures and work instructions used to deliver training and give instruction to achieve the highest possible standards across our range of medical devices and procedure packs.
For questions about our company, our product range, or any other matter, please contact us on +44 (0) 1332 794880 or email us at firstname.lastname@example.org
Yes, all of our products are both Latex and DEHP free – unless specifically requested by a customer. For example, we can provide latex gloves in our Procedure Packs if required.
For Regulatory and Technical information, Technical Data Sheets, are available upon request. All Technical Data Sheets, and other supportive documents, are stored in our distributor login area of the site. If you require access to these documents, please email us email@example.com and we will be happy to help.
We are committed to minimising our direct impact on the environment and are continually working towards improving our environmental performance and integrating recognised best practice into all our business operations.
We currently hold an ISO 13485 accreditation, whilst our clean rooms operate to BS EN ISO 14644-1 standards.
We were proud to become an Employee-Owned Trust in 2021, ensuring the business stayed in the city of Derby, whilst at the same time recognising staff for their hard work and commitment throughout the years. Being an EOT means that staff are central to everything we want to achieve as a business.