Process Quality in Manufacturing of Medical Devices

Liquid-based medical devices are closely linked to patient hygiene, whether it’s about skin, instrument or surface disinfection. This means that reliable risk management is vital throughout the production process, which in turn sets the bar high for contract manufacturing. A controlled and certified, expertise-driven production adds the most value to the contract giver.

Liquid-based medical devices include skin disinfectors, stoma care products and disinfectors for medical instruments and surfaces. The contract manufacturing of medical devices requires extensive expertise.

– In medical device manufacturing it’s essential to assess the risks even before the production begins. Production is preceded by a huge amount of planning, testing and documentation. Validated processes and meticulously designed products are essential to achieving results, says Jesse Arjaluoto, COO at Teampac.

The initial stage of the production process is much longer for medical devices than for other liquid-based products, such as cosmetics. Process quality and compliance are ensured by ISO 13485 standards, the criteria for which have recently been made even stricter.

– Our reliable, high-quality production meets the stringent documentation requirements of the standard, which guarantee the safety and manufacturability of the products. We must also ensure consistent quality and traceability.

A strategic partnership based on trust

A strategically chosen contract manufacturer is a partner who can add value for the customer with effective process management and an expertise-based approach. Although efficient and secure production is a basic requirement, there is increasing demand for expertise that covers the entire product process. In addition to careful initial planning and testing, the importance of change management, for instance, should never be underestimated.

– Possible changes to the product can be made according to a carefully defined, documented change management process. No changes, not even minor ones, are made without the permission of the customer, who launches the product to the market”, Arjaluoto emphasises.

Not all contract givers necessarily know the strict requirements for medical products. A trusted contract manufacturer will tell the customer if some requirements are not met and explain the practicalities of rolling out a product of a particular medical device classification. Responding to the customer’s requests and ideas requires not only considerable expertise but also a network of specialists to turn to in challenging situations.

– Trust is vital in successful contract manufacturing. Whether you’re working with an international industry leader or a local growth company, your aim is to help the customer’s business thrive. Certified processes and expertise that can be channeled to reach the customer’s goals are the keys to achieving this,” Arjaluoto says.

Teampac’s quality management system is certified with the ISO 13485:2016 standard specific to medical devices, which covers contract manufacturing and sales.