Specialties · CE and FDA / GMP certification
CE marking and FDA / GMP compliance for medical and laboratory equipment
We handle the entire regulatory side so your equipment can be sold in any market: CE marking, FDA documentation and design in line with Good Manufacturing Practice (GMP), with IQ/OQ/PQ validation when the customer requires it.
What we do for you
CE marking: Machinery, Low Voltage and EMC Directives
Documentation for FDA 510(k) submission
GMP-compliant design and IQ / OQ / PQ validation
Technical file and declaration of conformity
Every machine we build runs on a custom PLC
Each machine is controlled by a PLC (programmable logic controller) programmed specifically for your process: recipes, alarms, data logging, HMI touchscreen and connection to your systems. We develop it in-house, together with the machine.
Equipment and applications
- Medical and diagnostic equipment
- Laboratory equipment
- GMP pharmaceutical production
- Export to Europe, the US and Asia
People also find us for
- CE marking equipment
- FDA certification
- GMP compliance
- IQ OQ PQ validation
- medical equipment certification
- medical device CE marking
Have a project in this field?
Tell us what you need. We design and manufacture the equipment under your brand and handle the regulatory side so you can sell it.