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About Us

Who We Are

  • Blue Pearl Medical is a full-service consultancy firm that helps medical device designers and manufacturers navigate the complex and constantly evolving medical device life cycle; concept, planning, design, validation, launch, and post-market


  • Each member of our team of expert consultants has over 25 years of experience in the minimally invasive medical device industry with proven track records in bringing complex Class III devices through to regulatory approval and commercialisation into global markets


  • Specialities include Innovation, R&D, Medical Device Project and Program Management , Design Assurance, Reg Affairs, Quality Assurance, Manufacturing and Supply Chain Management

Our Clients

Who We Support

We offer expert support for all stages of the medical device product life cycle


  • Physician(s) and their unmet needs
  • Venture Capital & Private Equity Businesses
  • University Technology Transfer Offices
  • Innovation Hubs
  • Medical Device Start-Ups
  • Small-to-Medium-Sized Medical Device Companies
  • Established Medical Device Companies
  • Medical Component Suppliers
  • Contract Manufacturing Organisations
  • Medical Device Distributors
  • Hospitals, Clinics and Medical Facilities

Our Services

Project/Program Management

Project/Program Management

Project/Program Management

Project and Program Management graphic

Expert support in planning, coordination, and execution of medical device development projects


This service includes defining project goals and objectives, establishing schedules, allocating resources, and tracking progress to ensure that projects are completed on time and within budget


The Medical Device Project and Program Management service also helps you effectively manage risk, maintain quality control, and ensure that projects are executed in compliance with regulatory requirements


The goal of project management services is to help you successfully bring your products to market by effectively managing the many complex and interrelated components of the development process

Technical Advisory

Project/Program Management

Project/Program Management

Light bulb depicting technical complexity

Expert support and guidance on technical issues related to the development, design, and manufacture of medical devices


This service helps you navigate complex regulatory requirements, improve product performance and functionality, and address any technical challenges that you are facing during the product development process


Technical advisory services aim to help you bring your products to market efficiently and effectively, while ensuring that they meet all necessary standards and regulations

R&D & Design Control

Project/Program Management

Grant Aid Submissions

FDA Design Control best practices

Expert support and guidance during the research and development and design control phases of product development 


This service includes support in identifying and assessing new product ideas, developing prototypes and design concepts, and implementing design controls to ensure that products meet all necessary standards and regulatory requirements


R&D and Design Control services help you bring new and innovative products to market by providing expert support and guidance throughout the development process


The service also helps you manage risk, maintain quality control, and ensure that products are designed and developed in compliance with regulatory requirements

Grant Aid Submissions

Supplier and Contract Manufacturer Assessments

Grant Aid Submissions

Business man holding 2 jigsaw pieces together

Assistance in the submission of claims for tax credits and grant aid related to your research and development activities


This service includes preparing and submitting claims, providing guidance on eligibility criteria, and advocating on your behalf  to ensure that you receive the full benefit of these programs


The objective of R&D tax credit and grant aid submission services is to help you receive financial support for your R&D activities and offset the costs associated with bringing new products to market


By maximizing the benefits of these programs, R&D tax credit and grant aid submission services help you continue to invest in research and development, bring new and innovative products to market, and drive growth and competitiveness in the industry

Due Diligence

Supplier and Contract Manufacturer Assessments

Supplier and Contract Manufacturer Assessments

Due Diligence - peeling back the surface

A comprehensive evaluation of potential medical device products, technologies, and companies


This service includes the review of product design and development documentation, regulatory compliance history, intellectual property status, and market potential, among other factors


The objective of due diligence review services is to provide you with a thorough understanding of the strengths and weaknesses of potential products, technologies, and companies, and to help you make informed decisions about which products and technologies to pursue, and which companies to partner with


Due diligence review services help you manage risk, ensure that you are investing in high-quality products and technologies, and make informed decisions about your future product portfolio and growth strategy

Supplier and Contract Manufacturer Assessments

Supplier and Contract Manufacturer Assessments

Supplier and Contract Manufacturer Assessments

Robust review process

Evaluate potential suppliers and contract manufacturers for medical device components and product


This service includes conducting thorough due diligence to assess a supplier's or contract manufacturer's capabilities, quality control processes, and regulatory compliance history


The objective of supplier and contract manufacturer assessment services is to help you make informed decisions about which suppliers and contract manufacturers to work with, and to ensure that these partners are capable of meeting the high standards required in the medical device industry


This service also helps you mitigate risk, maintain quality control, and ensure that their products are manufactured in compliance with regulatory requirements

Bringing Physician Ideas To Life

Bringing Physician Ideas To Life

Bringing Physician Ideas To Life

Series of light bulbs with one lit

Expert support provided to physicians in the development of your medical device ideas and concepts


This service includes help with the identification of market opportunities, the development of prototypes, and the creation of business plans to bring the product to market


The objective of bringing physician ideas to life services is to provide you with the resources and support you need to bring your ideas to life and to help  navigate the complex and often challenging process of developing and bringing a new medical device to market


By providing expertise, guidance, and support, these services help to increase the chances of success for physician-led medical device projects and promote innovation in the industry

With the right people anything is possible


Sir Richard Branson

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Blue Pearl Medical

GALWAY, IRELAND

EMAIL: INFO@BLUEPEARLMEDICAL.COM

Copyright © 2023 Blue Pearl Medical - All Rights Reserved.

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