Customer focus

Devices contract manufacturing - how does ISO 13485 secure customers? Union Plastic explains

Medical device manufacturers have to comply with stringent regulations to access the European market. Those European regulations are changing quickly and the coming years will see the publication of the Medical Devices directive RECAST, which will oblige the industry to make changes, regarding device master files and other issues. The first step is the implementation of harmonised standards, and the first of them is ISO 13485.

In the meantime, a new European regulation 2013/473/UE already prepares the next changes in the medical device industry. It has applied since 2013 to all notified bodies (NB), which certify medical device manufacturers, by strengthening their responsibilities and field of investigation.

Appendix II Chapter 19 of this regulation gets upstream in the supply chain, by clearly involving Contract Manufacturing Organizations (CMOs) in the final product quality. This defines critical sub-contractors, which design, manufacture or perform services for a part of the medical device, and critical suppliers, which supply essential components as raw materials and molded parts. Those organisations shall keep under the control of their order giver and his NB, which must perform planned and unannounced audit in their premises too.

For instance, if medical device manufacturer A purchases from and injection moulding company B a single component that is assembled by A in a complex medical device, regulation 2013/473/UE obliges A’s notified body to audit B them versus the same standards as A. It is also stated that B’s ISO 13485 certification can justify lightening such audits.

Union Plastic, a French CMO with half a century under its belt working with partners in the device, diagnostics and pharma industries, has anticipated this trend for long. Specialising in providing complex injection moulded thermoplastic parts and assembling solutions, the company renewed its ISO 13485 certification several times, which covers all its businesses and activities from the design phase to the warehousing.

This certification had a positive impact on the quality management system (QMS) of the company and it also helped in becoming the contract manufacturing partner of choice for the world's most successful companies.

Being CMO and manufacturer too, talking the same language and having the same regulatory restrictions as its main customers, Union Plastic says it went deep in the implementation of the medical device reference quality standard, with improved processes and procedures, from the product design to the final release, including batch records and qualification.

In addition to this positive implication on the company business development, typical benefits from the ISO 13485 to CMOs are:

Efficient and health-focused QMS.

Increased safety during the product design: Risk Management Process, according to the ISO 14971 standard, is daily used by Union Plastic for each medical device or component development.

Union Plastic enlarged the use of this tool to each new part, even when it is a sub assembly of the medical device, during each critical step: design review, prototypes review, design validation, and industrialisation.

Quality Assessment is carried out over all design stages at in each product design from a very early stage, through a dedicated Quality Project Expert.

Change Control: all medical device manufacturers need to monitor and manage the activity of their CMOs. So they have to be informed about change, which impacts the component. Having efficient and transparent change control procedures led Union Plastic to win the trust of the main order givers.

Traceability: ISO 13485 is a very good guideline to improve traceability from raw material source to finished products, records and inspection reports.

Sterile products handling: ISO 13485 is now a must when choosing contract sterilizers, especially with companies dealing with several industries like food or cosmetics.

This demonstrates, says Union Plastic, that choosing a contractor is not only a technology driven decision process. The component user has to find out a partner, which has a structured approach and knows the downstream applications of their components. ISO 13485 is not the universal key to understand it, but it very much helps CMOs in implementing health-focused processes.

And last but not least, the 2015 release of this standard should go further in the requirements to be applied to subcontractors - this must be anticipated now says the company.