Post-Market Surveillance Powerful PMS systems for safer medical devices

Complete MDR Post-Market Surveillance system design and implementation by medically-trained specialists.

Unlocking MDR compliance through innovative PMS design

Developing a PMS system to meet MDR standards is a specialist and complex task that requires extensive knowledge of clinical data collection and analysis.

Our MDR-trained medical professionals are proficient at applying their clinical expertise to the design and implementation of PMS systems for the MDR.

  • Complete PMS service

    We work with medical device manufacturers in all sectors of the market and at all stages of development.

  • Tailored development

    We manage the entire PMS process, working in harmony with existing processes to minimise cost.

  • Focus on MDR compliance

    PMS systems produced in accordance with MDR Article 83 and relevant MedDev guidelines.

Our PMS process

Mantra Systems' PMS process

Our PMS design service begins with a free consultation to discuss your requirements.

We then develop a tailored, individual proposal before commencing definitive PMS design and production of MDR Annex III technical documents.

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Adaptive PMS design tailored to your requirements

Whether it's building an entire PMS system or updating an existing framework, our medical experts provide just the support you need.

We provide a unique service with unparalleled medical insight, streamlining your transition to MDR compliance.

  • Design, implementation & maintenance

    Expert, modular PMS services designed to meet your specific requirements.

  • Dedicated build of PMS elements

    Development of PMCF and vigilance systems that form essential components of all MDR PMS systems.

  • Technical documentation

    PMS Plans, Reports and PSURs written by dedicated medical professionals.

Call us now to discuss your MDR requirements:

(+44) 0114 386 3349

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MDR Consulting

Our team of medical doctors are specialists at building the clinical evidence portfolio that you need for MDR compliance of your products.

Download our free Post-Market Surveillance in the MDR White Paper

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MDR Training

Our comprehensive training services are delivered by experts and address all aspects of MDR compliance.

MDR Guidance

Our unique MDR guidance resources are written by our medical experts and free to use. They cover all aspects of the new Medical Device Regulation.

Do you have any questions about our MDR services?

Contact us