What We Offer
We offer a spectrum of services to help our clients gain market access and compliance support. Everything from creating dossiers for compliance or creating a quality management system to work in more effective ways to suit, and training and updating your team with new regulations around the world, and helping you be abreast and in compliance to these new regulations.
We provide and combine multiple services that are tailored to your business requirements by removing the complexity and unnecessary cost of getting multiple parties involved.
To understand more about the services, we offer please click below to view all our services.
All our services are bound to ISO 13485 Standards.
Global regulatory compliance, keeping you abreast and supporting you achieve regulatory compliance and ensuring market access.
Supporting you with systematic procedure according to the required standards.
Different markets have different language requirements. We support all languages around the world and translate using Human translators with expertise in the medical field.
With the new medical device regulation, and Importer is required to gain market access to EU and Swiss markets. Furthermore, an Importer of Record is required for the Great Britain market.
What our clients are saying!
UK Responsible Person
We have worked with OMC Medical over a year and OMC serves us as UK Responsible Person and have found them to be supportive and informative team on this activity. Their team is quick to respond and action on our requirements.
OMC Medical is thorough on their process and takes time to understand our concerns and to answer our queries, we recommend OMC Medical to other medical device manufacturers. If you have any questions please free to contact us.
– Miriam, Head of Quality Management and Regulatory Affairs
CE, UKCA, FDA Marking
I have worked, and I am still working, with OMC Medical for our medical device project. We have worked with OMC Medical to write technical documentation for our product which includes CE marking, FDA marking and UKCA marking. We strongly recommend OMC Medical to any other medical device manufacturers in the market to obtain regulatory certifications and other regulatory needs. OMC Medical has worked to tight deadlines and always to the highest quality.
Their knowledge and attention to detail with the changing regulatory scope has been very impressive. I feel confident in recommending OMC regulatory services. I have actually recommended them to 4 other clients in the past 3 months.
OMC Medical is not only thorough but also easy to work with and always willing to take the time to discuss my concerns and respond to questions.
– Dr. Mat, CEO
UKRP, Swiss AR and Swiss Importer
I am impressed by the speed that OMC Medical responds to customer requests. Very knowledgeable staff.
– Anonymous, RA/QA Manager
Swiss AR and Swiss Importer
Service minded. OMC Medical were able to customize a solution that works well with our needs.
– Anonymous, Head of Quality and Regulatory Affairs
OMC Medical Team Consultants have been a big help in supporting our risk management activities to comply with EU MDR requirements for medical devices. They have demonstrated technical and compliance expertise, been responsive to time-sensitive projects, and conducted themselves collaboratively and professionally.
– Anonymous, Regulatory Specialist
Swiss AR and Importer
Flexible and service-minded.
– Anonymous, Quality and Lean Co-ordinator
Very smooth to work with OMC medical, always helpful and eager to help.
– Anonymous, Director, Quality and Regulatory