SERVICES – MEDICAL DEVICES

LEM Compounding Research is authorized to manufacture medical devices according to ISO 13485 certification.

We are able to produce and develop class 1, 2A, 2B and 3 devices.

Thanks to the Clear Room, LEM CR is able to make sterile topical products.

Rely on our pool of experts for the formulation, implementation and registration of your medical device.

We are able to finalize it from the first stage to the final stage, together with the creation of the technical file.

ISO 13485

The ISO 13485 standard “Medical devices – Quality management systems – Requirements for regulatory purposes” in Italian “Medical devices – Quality management systems – Requirements for regulatory purposes” identifies a standard for the specific quality management system for companies in the medical sector, which includes aspects of the ISO 9001 standard and specific requirements for the medical device industry.

The ISO 13485 standard is certifiable, or it is possible to obtain it from an accredited certification body that operates within certain rules, attestations of compliance with the requirements contained therein.

OUR CERTIFICATIONS