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ISO-13485 Ready

Forme Technologies provides its services to a wide range of customers in industries that demand exceptionally high quality, traceability, and dimensional performance. A significant percentage of our clients are part of the biotechnology sector, where stringent attention to quality requirements is a must.

At Forme, quality is not an option, it is a de-facto reality. We understand how quality not only benefits our customers, but also helps to drive internal improvement processes that ultimately translate to positive impacts on the bottom line for our shareholders. This philosophy is what has driven Forme Technologies from their beginning and initially the acquisition of their ISO 9001 certification. As a result of our customer requirements and expectations as well as our own internal philosophy of excellence, ISO 13485 became the natural progression path towards achieving the ultimate in quality management systems.

Along this journey, Forme had initially been contracted to manufacture devices and products under the banner or auspices of an ISO 13485 certification, with the credentials being carried by our customers and not ourselves. Whilst this worked for a while, it became very evident that the heightened requirements for external auditing etc was going to be overly burdensome and as a result, Forme secured its own ISO 13485 certification for manufacture in May of 2022. Whilst this negated the requirement for excessive documentation etc in order to survive scrutiny, it is a testament to Forme's ability to achieve the highest quality standards even without a certification. It further bears testimony to the fact that Forme “lives” its quality principles outwardly as opposed to brushing up its system in the face of oncoming audits.

Further to this and as a part of Forme’s management strategy to fill a gap in our offering for our biotechnology clients, Forme Technologies built a state-of-the-art manufacturing facility that includes a 220 m2 cleanroom housing both injection moulding as well as added value capabilities. By May 2022 Forme was operating its own ISO 7 cleanroom as well having secured ISO 13485, and ISO 9001 certifications.

Our ISO 13485 certification is evidence of our commitment to quality, and a testimony of how seriously we regard every step of our production processes so that we can guarantee the efficacy of the products we manufacture, which ultimately translates in a benefit to the people using them.

For our clients, our ISO 13485 means that they can have additional peace of mind with respect to the quality and safety of their products, whilst retaining the traceability and manufacturing history of their devices from raw material to finished goods. As the ISO 13485 certification is globally recognised it will go a long way in easing the approval processes of our customers’ medical devices with respect to regulatory requirements etc , consequently providing easier access into the market.

At Forme Technologies quality is not an option it is a “de-facto reality”.

Cleanroom manufacturing facility in Melbourne
Forme Technologies can manufacture, assemble and package your products inside our 220 sq metres ISO 8 cleanroom. Our ISO 13485 certification can facilitate your regulatory path and into market.
Quality Assurance
We are both ISO 9001 and ISO 13485 accredited businesses. We guarantee that our manufacturing, testing and assembly are in our state-of-the-art facility-controlled and optimised clean environment.




ISO 8 Cleanroom


ISO-13485 Ready

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