Services

The Entaco Medical team can contribute and support medical device projects from concept to launch - Including design and regulatory services working in collaboration with proven 3rdparty service providers. Our experienced technical team can contribute and undertake validation activities to support CE Marking, 510k or PMA submissions. Concurrent engineering and quality planning enable Entaco Medical to fully integrate our sub-contract processes into any supply chain.

ISO 7 (Class 10,000) validated cleanroom suites are environmentally controlled, rigorously maintained and continuously monitored to ensure to highest degree of

compliance to ISO 14644 - Cleanrooms and associated controlled environments. Our

planned workflow and compliance with the requirements of our QMS ensure all cleaning and packing activities are carefully controlled.

We have the ability to clean, pack and label devices providing a total supply solution for customer products. All equipment is validated and maintained within the QMS. Blister and Peel Pouch packaging options are available to suit customer preferences. In process packaging testing is routinely performed to demonstrate consistent seal Integrity.  Entaco Medical can also manage packaging design concepts working with the customer to achieve exact requirements.

At Entaco Medical, we provide a flexible one-off contract packaging service within our controlled environments, ensuring the highest standards of quality and cleanliness. This service is ideal for customers requiring short production runs, bespoke packaging solutions, sample preparation, or specialist kit assembly. Operating under ISO 13485 and ISO 9001 standards, we maintain full compliance, traceability, and product integrity throughout the process. Our experienced team works closely with clients to deliver tailored packaging solutions, offering a reliable and efficient service with complete quality oversight from start to finish.

Prior to supply, Entaco Medical can outsource all sterilisation processes to industry approved suppliers for Gamma Irradiation, Ethylene oxide (ETO) and Gas Plasma Sterilisation, providing a terminally sterile device ready for use.

• Supply of injection moulded components
• Passivation to recognised standards
• Aqueous Ultrasonic Cleaning
• Cleaning Validation
• Component Assembly
• Packaging and label design
• Full packaging selection and sourcing
• Peel Pouch Packing
• Blister Packing
• Packaging integrity testing & monitoring
• Packaging Validation inc. accelerated aging testing
• Control of sterilisation and sterilisation validation
• (Gamma Irradiation, ETO and E-Beam carried out
• in partnership with approved suppliers)
• Routine sterilisation dose audits
• Supporting Quality System documentation
• Supporting Technical authorship or
• documentation and validation services