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.

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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

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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 
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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 
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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
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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.  

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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.

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Meet the Medical Device Experts

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Núria de la Fuente

Medical Device Senior Consultant/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.

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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.
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  • +34 934 178065


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  • Hyderabad, India