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Leading Medical Device Consultant and Certification Provider in the UK | Operon Strategist
Welcome to Operon Strategist

Medical Device Regulatory Consulting in the UK

We are one of the leading medical device regulatory consultants in the UK. We offer clients an array of services, like turnkey services, system implementation, training, licencing, regulatory approvals, and certifications for the UK.

Leading Medical Device Consultant in the UK

Operon Strategist is a United Kingdom regulatory consulting company that provides regulatory guidance to various medical device manufacturers in the healthcare industry to ensure the strategic development of these manufacturers. We serve our clients by providing turnkey services, system implementation, training, licencing, regulatory approvals, and certifications. We provide customised solutions to manufacturers looking to set up a world-class manufacturing unit.

Our team has expertise in MHRA medical device registrations for the UKCA. We have a reputed client base in the United Kingdom.

Get in Touch for your medical device consultation

UKCA, FDA, CDSCO and CE.

Medical Device Regulatory Consulting Services in the uk

UKCA for medical devices
UKCA MARKING
ISO 13485 - QMS
CE MARKING
MANUFACTURING FACILITY
FDA (510)K
CLEAN ROOM DESIGN