Medical Devices

Rephine provides innovative and scalable solutions to meet the quality and compliance requirements of the Medical Devices sector

The design, manufacture and marketing of Medical Devices represents a wide and diversified field of activity within the Life Sciences sector and, as such, subject to compliance to strict and continuous evolving regulatory principles, as we can see, for example, in the new European regulations: 2017/745 and 2017/746.

Medical Devices

Rephine will undoubtedly contribute to the success of your projects by ensuring not only the highest levels of regulatory compliance throughout the product life cycle, but also that they will be carried out with the maximum guarantees of safety and performance in the absence of risks for the patient or user of the final product.

From Rephine we offer different assistance services to our clients and partners, all of them focused on accompanying them in the rigorous and efficient fulfillment of all the applicable regulatory requirements for the design, development, production, commercialization and post-market activities of your Medical Devices.

What Rephine Offers

GxP Consultancy

Medical Device Classification

GxP Consultancy

Medical Device Software

GxP Consultancy

Market Authorisation compliance with Health Authorities

GxP Consultancy

Quality Management System

GxP Consultancy

Medical Device Risk Assessment

GxP Consultancy

Technical File

GxP Consultancy

Supplier and Internal Audits

Medical Device Value Chain

We provide integral support during the development, production, certification, commercialization and post-market follow-up of medical devices, including in-vitro diagnostic products and medical device software (MDSW) in Europe and USA.

We offer different services along the entire value chain of medical devices, aimed at meeting the quality objectives and regulatory requirements in each case.

GxP Consultancy

Consulting and advice

Marketing process in the United States:

  • Classification of the Medical Device
  • 510(k) and PMA submission


Design and implementation of Quality Management Systems

  • Based on ISO 13485 and 21CFR Part 820
  • Risk management based on ISO 14971
  • Design and development of Software as a Medical Device according to IEC 62304
  • Post-Market Surveillance

Approval of suppliers

  • Risk-based supplier classification
  • Supplier Risk Assessment
  • Preparation of Quality Agreements / Audit Questionnaires
  • Supplier audits

Qualification and Validation

  • Manufacturing Processes of Medical Device
  • Manufacturing Equipment and Facilities
  • Computer systems associated with Medical Device
  • Stand-alone Computer Systems and Mobile Applications (Medical Device Software)

Where do you Need our Help?

For GMP Auditing, Quality Assurance & Digitalisation, we’re the partner of choice for all the stakeholders we deal with.

We provide extensive GMP consulting services to help keep our clients ahead of the needs and expectations of regulators.

Browse Audit Library

GMP Audit Services

GxP Consultancy

GxP Consultancy

Global Audit Library

Global Audit Library



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Let's get in touch

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