Quality System

Redditch Medical has invested significantly in purpose built manufacturing facilities in both Redditch and Durham.

Accreditations

Our medical division is registered to ISO 9001: 2008 and BS EN ISO 13485: 2003 and includes state of-the-art Cleanrooms operating to GMP for manufacturing and assembly. 

We are U.S. Food and Drug Administration (FDA) registered under registration 8043734 and manufactures and packs medical Devices for USA customers under FDA QSR 21 CFR 820. 

We also hold the Canadian ISO 13485:2003 licence required for selling goods to Canada. 

Download a copy of our certificates:

Quality Maintenance

At Redditch Medical our Quality Assurance is managed by an experienced Quality Assurance Manager. With a low turnover of staff we are regularly audited and have an excellent compliance history. Our operators are extensively trained on the specific details of any process or device assembly. We have an open book approach with our customers and are happy to share our Quality System with our customers on any quality issue or CE Marking.  

We have worked with many customers, including start up and international companies, on the design, development and assembly of global products right through to launch and distribution. 

We are registered to ISO 9001:2008 and BS EN ISO 13485:2003. We manufacture and package medical devices for USA customers under FDA QSR 21 CFR 820. GMP accredited containing EN ISO Class 5 & 6 Cleanrooms for contract pharmaceutical manufacturing.

Sterilisation processes

Our sterilisation processes are validated regularly during the year to ensure Sterility Assurance Level (SAL 10-6). Our sterile products are presented in single use packaging, and which has the necessary seal strengths to maintain seal integrity during sterilisation, transport and storage. Where required we can provide multiple barriers for product protection. 

Quality Management System

Our Quailty Management System (QMS) meets all the requirements of ISO9001, ISO13485, 21 CFR 820 and we incorporate Good Manufacturing Practice (GMP), Lean Manufacturing techniques and use industry recognised IQ/OQ/PQ validation methods or GAMP methodology.  Our subsystems fully integrate customer feedback, CAPA, PPAP, continuous improvements and Risk Management to ISO 14971.  Our Product Development process is guided by the guidelines set out in ISO 13485. Our contamination control products are BPD compliant.  all system are regularly audit using an established internal audit systems and from our notified body Intertek.

  • GMP  Good Manufacturing Practice
  • GAMP  Good Auotmated Manufacturing Practice
  • PFMEA  Process Failure Mode and Effect Analysis
  • PPAP Production Planning Approval Process
  • CAPA  Corrective Action Preventive Action
  • OQ  Operational Qualification
  • IQ  Installation Qualification
  • PQ  Performance Qualification
  • SPC  Statistical Process Control

Our Purpose built Cleanrooms

Our Durham facility operates to current Good Manufacturing Practice (cGMP). The manufacturing area, goods in and out are all specified to ISO 6. Product is filled under ISO 5 localised air shower allowing critical contract pharmaceutical manufacturing.  

We have developed comprehensive, validated technical files for the products made on this site which contains product details and associated microbiological and shelf life validation data. 

We are happy to share these with our customers.
Please contact us for more information.

Contact us

Please call our team on U.K. 0845 0739529, International +44 (0) 1527 830942 or fill in the form below, and we will be in touch at the earliest opportunity:

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BPR

BPR

We have excellent facilities including an ISO 5 Localised Air Shower, ISO 6 and ISO 7 Cleanrooms and a ISO 9 Control Room that can be used for both sterile and non-sterile devices.

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