Medical device electronics with ISO 13485 quality
We populate, assemble and test electronics for medical devices in an ISO 13485:2016 system certified by SGS. Our longest medical device customer relationship has lasted over 20 years.
ISO 13485:2016 – the same system for every order
Our quality system has been certified by SGS Fimko Oy since 2019, and SGS audits it annually. The same system, traceability and nonconformity process apply to every order – including those that are not medical devices.
- Certificate number
- FI19/5163
- Issued by
- SGS Fimko Oy
- Certified
- since 2019
- Valid until
- 18 July 2028
- Scope
- Electronics contract manufacturing and related services
- Copy
- Request the PDF
What to require from a contract manufacturer – and how it works with us
The EU Medical Device Regulation (EU) 2017/745 requires the manufacturer to control its subcontractors as well. With these eight points in place, supplier evaluation and audits run smoothly.
The scope covers contract manufacturing
Check that the certificate covers exactly the work you are buying. Our scope is electronics contract manufacturing and related services.
Controlled component sourcing
Components and PCBs are purchased from approved suppliers in line with the quality system, and purchases are traceable.
From the delivery back to the materials
Each delivery's declaration of conformity records the products, quantities and serial numbers, together with the materials used, their suppliers and traceability data. Inspection and test results are archived.
No changes without your approval
Component substitutions and process and test changes are made only after your approval, and they are documented.
Root cause and corrective action
Every nonconformity is investigated down to its root cause and reported in a nonconformity report – for manufacturing defects, our target is within two weeks of the product arriving for analysis. The corrective action shows in the following batches.
The door is open
Customer audits in Kemijärvi are welcome, and SGS audits our system annually.
Responsibilities in writing
When we manufacture a product from start to finish, we sign a manufacturing agreement. A non-disclosure agreement is always available on request, and a quality agreement can be made on your own template.
Documents kept for years
Manufacturing records are retained in accordance with the quality system and customer requirements, and they are available for audits.
From circuit board to tested device
For medical devices we manufacture circuit boards (SMT and THT), control units and finished devices including final testing. Hidden solder joints are inspected by X-ray and every board under the microscope.
Small and medium-sized series are typical for medical devices. We have no minimum order quantity, and the same product can be manufactured unchanged for years – exactly what an approved device needs.
Read the story: a medical device manufacturer for over 20 years →
Changing manufacturer in the middle of the product life cycle?
For a medical device, changing manufacturer is validation work. We carry out the transfer via a pilot batch and first article inspection, and it is worth keeping the old manufacturer running in parallel until the pilot has been approved.