Capabilities and facilities
Cleanroom
DTR Medical is able to provide a complete cleanroom contract manufacturing service in particular for Medical Device Manufacturers and designers. The company currently produces a range of sterile medical devices for a number of contract customers, including Class three devices.
The high levels of accreditation we have achieved, ISO9001:2008, ISO13485:2012 and the capability to meet the European Medical Device Directive 93/42/EEC, creates the opportunity for us to undertake contract manufacture for third parties.
DTR Medical has two ISO Class 7 (Class 10,000) cleanrooms along with an experienced production and quality team. The facility contains both specialist assembly and packaging machinery to easily handle a wide range of medical devices.
Expertise & Track Record
The Production and Quality teams have a wide range of experience- from medical device & diagnostic manufacturing to high volume fluid filling. The cleanrooms are manned by fully trained operators, who have expertise in the packing and assembly of both dry and wet products.
We have many existing contract customers ranging from major multinational companies to local UK operators. The majority have audited our facilities regularly and DTR Medical has developed long term relationships with most of its customers. To cope with this extensive range of both products and customers the company has developed internal systems to take on and evaluate the manufacturing of new products. This ensures that a project is planned accurately from the start, which leads to more accurate quoting and often avoids costly delays later on.
A key reason for the success of DTR Medical’s contract business is the fact that the company operates to the highest standards and with complete confidentiality.
Contract Services
We are able to offer:
- CE Marking
- Medical device assembly
- Cleanroom packing
- Sterilisation services – we have contracts for gamma and steam
Contract Manufacturing Opportunities
DTR Medical has the capacity to take on more contract work across the range of services offered. For further information on its contract manufacturing service, if you would like to visit the facility or to discuss your CE marking project please contact on mfranks@dtrmedical.com or telephone +44 (0) 1792 797910