Welcome to Operon Strategist

Medical Device 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.

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turnkey project consultant

Turnkey Project Consultants

regulatory consultant

Regulatory Approvals

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.

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UKCA, FDA, CDSCO and CE.

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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
MORE SERVICES

Testimonials

5/5
“We have had good experience working with OperonStrategist the Medical Device Consultant, The team is experienced, Knowledgeable, result oriented, committed and professional in training and execution of the project, We strongly recommend Operon Strategist for all the services”
operon strategist
Arun Kumar - Director
MP Qatar Trading, Qatar
5/5
“Operon Strategist is an outstanding medical device consulting firms with whom I will do business again and these are my reasons. A true problem solver Very Reliable”
operon strategist
Zak Kouloughi - President
Tradeline Medical Lab, USA
5/5
The Team at Operon Strategist is reliable to work with & they provide excellent regulatory consultancy. They provide round the clock support & all their efforts are much appreciated.
operon strategist
Dr Apurv Patwardhan - Director
Australian Orthopedic Pvt. Ltd, India

What Our Client Says

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