Your reliable partner for medical technology
Innovative solutions and wide-ranging expertise make BECOM the ideal partner for developing and producing Class I, II and III medical products. Thanks to established contacts within the authorities, BECOM provides its clients with reliable advice and guidance concerning every test and approval process.
Our own in-house test facilities and specially trained personnel guarantee optimal safety for clients and patients at every stage of the working process. BECOM is able to win over established major clients and innovative startups in equal measure with flexible structures and many years of experience.
Standards and directives
- ISO 13485:2016
- ISO 60601 series (general standard for electronic medical devices)
- ISO 62304 (medical device software)
- MDD 92 / 43 / EWG (EU directive on medical products)
- IVDD 98 / 79 / EG (EU directive on in vitro diagnostic medical devices)
- RL 90 / 385 / EWG (EU directive on active implantable medical devices)
- Medical Devices Act of the respective country issuing approval
Neuro Appliance, Otto Bock, Roche Diagnostics, Schrack Seconet