Our production facility manufactures bespoke cold and hot compression packs for therapeutic and symptom alleviating use. CE marked therapy lines conform to all class 1 medical (non-sterile, non-measuring) directives. Products are used mainly for post injection and procedure inflation control, soft tissue injury management and pre-treatment mobilisation.
All therapy products are supported with a master technical file – ensuring adherence to approved specification, manufacturing and quality process. This includes standard operation procedures managing deviation and risk assessment.
Materials and additives used in the production of CE marked therapy products each have their own safety and compliance documentation accompying due diligence safety reports on the products themselves.
· Phthalate free vinyl
· Di-ionised water
· Food grade thickener and Monopropylene glycol
· Pharmaceutical grade sodium acetate
We manufacture a fully compliant product with the highest level of detailed works order and labelling documentation. CE marked products will be labelled and packaged with conforming consumer information;
· Product name and code
· Batch number and date of manufacture
· Full user instructions and disposal instructions
· Consumer feedback and support contact information
· Appropriate safety information
Please direct any contract manufacturing enquires to;
Morgan Leadbitter – Director & CE Regulatory Liaison
T: 01202 811640