Medical Devices

Our experienced team of medical device consultants act as a partner ensuring regulatory compliance and quality assurance. We are driven by our enthusiasm to bring safe, effective and innovative medical devices to market. 

At Rephine, we place utmost importance on delivering a sense of comfort and trust to our clients, leaving them with the assurance that they are compliant with all relevant regulations and standards. With us, you can rest assured that your regulatory compliance needs are taken care of, allowing you to focus on your core business objectives.

Medical Devices service image.png

Regulatory and Quality Solutions

We are proud to possess valuable expertise in delivering end-to-end support and solutions to ensure regulatory compliance for medical devices at every stage of the product cycle.

Our services are intricately customisable, tailored to meet the specific needs and requirements of our clients from design and development to manufacturing, marketing, and post-marketing operations.

Expedited compliance processes are made possible through the streamlined compliance roadmaps crafted by our team of experts, saving time and money for both startups and multinational companies.

Our unwavering objective is to achieve success in all of our projects by upholding regulatory standards while prioritizing product safety and performance for patients and users

What Rephine Offers

regulatory consulting.png

Regulatory Consulting 

For both new products and legacy medical devices, our consultants can facilitate regulatory consulting to place medical devices to market. 

  • Regulatory Roadmap 
  • Medical Device classification 
  • MDR / IVDR checklist readiness 
  • Product Risk assessment: ISO 14971 methodology 
  • Gap remediation of defficiencies from NB / Health Authority review / inspection 
  • Ad-hoc consulting 
technical documents md.png

Technical Documentation 

Compilation of Technical Documentation following the specific regulatory strategy depending on the regional regulations. We also have significant experience in providing verification evidences such as for Medical Device Software (MDSW) and In Vitro Diagnostic (IVD) Medical Devices.  

  • Compilation of Technical Documentation 
  • Define claims for intended use and device description chapter 
  • Product Risk assessment 
  • How to evidence and justify General Safety and Performance Requirements (GSPR) and applicable standards 
  • Review of labels and Instructions for Use 
  • Design and Development documentation 
  • Functional verification for Medical Device Software  
  • Analytical Performance for IVD products 
  • Manufacturing / sterilization process validation 
  • Post Market Surveillance plans and reports 
QMS MD.png

Quality Management System

Medical devices must be managed under a quality system throughout their life cycle. Our extensive QMS expertise will ensure that quality management processes are defined and/or improved, facilitating associated regulatory compliance and continuous improvement. 

  • Implementation of QMS (ISO 13485 & 21 CFR 820): supporting you to QMS certification
  • Internal Audits/Gap Assessment: getting you ready for QMS certification
  • Suppliers Approval: supplier managements and suppliers audit (worldwide)
  • QMS Certification back office
  • Non conformities and CAPA management
MD audits.png

Person Responsible for Regulatory Compliance

For small companies we can act as the Person Responsible for Regulatory Compliance (PRRC), being permanently and continuously at your disposal. We can work together to define how to proceed to ensure the responsibilities and also train a person within your organisation to acquire the needed experience to be the internal PRRC in the future.  

Medical Devices service image.png

Medical Device Audits

Be confident with your QMS and with your outsourced activities and suppliers. Our consultants and auditors can bring you the best approach to improve internally and also to qualify your suppliers, specially critical suppliers that would be also audited by the Health Authorities.  

  • QMS Internal Audits 
  • FDA mock inspections 
  • Notified Body back office support 
  • QMS or Technical File gap assessments 
  • Supplier audit / supplier qualification 

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.

10 2.jpg

Meet the Medical Device Experts

IMG 3062 scaled.jpg
Nuria headshot .png

Núria de la Fuente

Medical Device Senior Consultant
& MD Area Manager

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



Related Resources

doctor performing medical research lab Blog

Navigating the Evolving Landscape of Cybersecurity for Medical Devices

Cybersecurity threats to the healthcare sector have become more frequent and more severe, carrying increased potential for clinical impact. Cybersecurity incidents have rendered medical devices
Read More
CE Mark MDSW Case Study Header Case Study

2023 Medical Devices CE Mark for a MDSW (Medical Device Software)

About this Case Study The case study involved CE Mark for a new Medical Device Software. The company has developed software that is considered as
Read More
Medical Devices service image.png Case Study

2023 Medical Devices Mock Inspection

About this Case Study The case study involved verifying GMP compliance in an IVD company to enable the commercialisation of their products in the USA.
Read More
GG PR blog header (5) Article

Rephine and Greenlight Guru Partner to Enable QMS for the Medical Device Sector

Rephine now offering QMS services to medical device companies through new partnership. Stevenage, Hertfordshire, 28 July, 2023 – Rephine, the experts in quality assurance &
Read More
IVD Tech file update Case Study Header Case Study

2023 In-Vitro Diagnostics Products Technical File Update

About this Case Study The case study involved updating the Technical File documentation for more than100 IVD products according to Regulation (EU) 2017/746. The company
Read More
Rephine Symposium Blue Back General

Rephine Virtual Symposium 2023 Video Recordings

About these recordings Missed out on the insightful sessions and captivating discussions from our esteemed speakers at the Rephine Symposium? Don’t worry, we’ve got you
Read More
UDI FAQs blog header Blog

Demystifying UDI Compliance: A Comprehensive Guide to Traceability in Medical Device Manufacturing

Aitor Rius – Medical Devices (& In Vitro) Regulatory and Quality Consultant, Rephine Beyond UDI assignment, there are more than a few new requirements in
Read More
Medical device Laia blog header Blog

Medical devices: navigating the latest EU regulatory frameworks

Laia París Coderch, PhD – Medical Devices (& In Vitro) Regulatory and Quality Consultant, Rephine At a quickening pace now, the regulations and quality/safety controls
Read More

EC Proposal Amending MDR & IVDR Transitional Provisions (2023)

EUROPEAN COMMISSION PROPOSAL AMENDING MDR & IVDR TRANSITIONAL PROVISIONS (2023) On February 16 2023, the European Parliament finally voted on the EU Commission Proposal about
Read More

Let's get in touch

Please get in touch. Our expert GMP audit team is only a click away, on standby to answer all your questions.
Social: Linkedin



  • Barcelona, Spain                               
  • +34 934 178065


  • Shanghai, China 


  • Hyderabad, India