Quality Management & Regulatory Affairs

"We supply high quality, safe products to meet our customers’ requirements at all times."

Quality Management System

TMH operates a Quality Management System which is certified as conforming to ISO 9001 and ISO 13485. The system is also compliant with FDA CFR 21 820, covering Quality System Regulation & Good Manufacturing Practice and with the Medical Device Directive MDD 93/42 EEC.

TMH employs a number of techniques to ensure attainment of appropriate quality standards, whilst maximising operational efficiencies. These techniques include:

• Six-sigma
• Continuous improvement initiatives
• Process capability monitoring, through the use of statistical process control methods

Regulatory Affairs

TMH has extensive experience of regulatory submissions for both disposable autoinjector and needle-free jet injector devices. In accordance with a client’s requirements TMH can complete, or assist with, regulatory submissions including collation of Technical Files, undertaking Risk Analysis and Design Validation.

TMH has received a number of approvals for its technologies in Europe (CE mark; Class IIa and Class IIb) and USA (510(k)).

For more information or to discuss your requirements please click here to contact TMH.