ALL in ONE by A.M.I.
Engineering – Regulatory Affairs
- Together, we develop your medical device! With a standardised process of development – from the idea to the product innovation.
- We provide you with the device master record. With this, you can apply for the conformity assessment in terms of the 93/42/EEC guideline.
- Turning and milling processing on 5-axis milling centres, long turning lathes and turning milling centres.
Stainless steel, titanium, aluminium and plastic are processed.
- Assembling in cleanrooms class 8.
- Multi-stage ultrasonic cleaning process for the cleaning of devices and reduction of the bacterial count.
- Mechanical and manual sterile packaging in blister or pouch. We are also glad to deliver to you the sterile packaged product – ready for your customers.