Leadership in Medical Device Outsourcing: Top Companies Revolutionizing Healthcare Manufacturing and Innovation

Rank

Company

Overview

Solution/Product Portfolio

Sales Geographical Coverage

Developments

1.

IQVIA

IQVIA is a global leader in healthcare intelligence, technology, and outsourcing services. Within the medical device outsourcing market, IQVIA provides comprehensive solutions ranging from regulatory compliance to product development and commercialization. Leveraging advanced analytics and extensive industry expertise, IQVIA assists clients in navigating complex regulatory landscapes and optimizing operational efficiency. Their services encompass regulatory consulting, clinical trial management, market access strategies, and post-market surveillance, facilitating seamless product lifecycle management for medical device manufacturers worldwide.

• Clinical Solutions
• Compliance Solutions
• Commercial Solutions
• MedTech Technology
• Regulatory Services

Americas, Europe, Asia-Pacific and Oceania, and Middle East and Africa

In July 2021, BREATHE and IQVIA collaborated to accelerate the early diagnosis and treatment of respiratory conditions. This strategic step of working together to improve health outcomes and quality of life for people living with respiratory conditions in the U.K. would ramp up the market.

2.

EUROFINS SCIENTIFIC

Eurofins Scientific is a leading international group of laboratories providing a comprehensive range of analytical testing services. In the medical device outsourcing market, Eurofins offers specialized testing solutions to ensure product quality, safety, and compliance with regulatory standards. Their services cover a wide spectrum, including material characterization, biocompatibility testing, sterilization validation, and microbiological analysis. Eurofins' state-of-the-art facilities and expert scientists enable efficient and reliable testing, aiding medical device companies in bringing innovative products to market while mitigating risks and ensuring patient safety.

• Chemical/Physical Analysis
• Microbiology & Sterility
• Packaging & Seal Integrity
• Biocompatibility
• Combination Products

Asia-Pacific, North America, Latin America, Europe,

In May 2018, Eurofins Scientific had increased the biopharmaceutical products testing footprint with an outsourcing agreement with Astellas in Japan. The product expansion took place due to the company forming an agreement with Astellas to outsource the internal testing laboratories named as Astellas Analytical Science Laboratories, Inc. (“ASL”). ASL has offered the test services with good manufacturing practices in Japan. The outsourcing had expanded the growing footprint in Asia Pacific, and provides a good platform to further expand in the biopharmaceutical products testing market in Asia.

3.

SGS Société Générale de Surveillance SA

SGS is a world-renowned inspection, verification, testing, and certification company operating across various industries, including healthcare. In the medical device outsourcing market, SGS provides a comprehensive suite of services to support manufacturers throughout the product lifecycle. From regulatory compliance and quality management to supply chain assessment and clinical trials, SGS offers tailored solutions to meet the diverse needs of medical device companies. With a global network of experts and accredited laboratories, SGS facilitates market access and enhances product reliability, enabling clients to navigate regulatory complexities and meet evolving industry standards.

• Clinical Research
• Packaging Testing
• Packaging Testing

Europe, Middle East and Africa, and Asia-Pacific, North America

In May 2020, SGS SA has expanded the Network of ISTA Labs and Adds ISTA’s 6-Amazon Certification Testing. The service expansion meant to maintain the package testing standards while outsourcing the medical devices and the need to protect products from damage throughout the supply chain without the need for additional packaging.

4.

Intertek Group plc

Intertek is a leading provider of quality and safety solutions, offering a wide range of testing, inspection, certification, and auditing services. In the medical device outsourcing market, Intertek assists manufacturers in ensuring compliance with regulatory requirements and industry standards. Their offerings include product testing, risk assessment, quality management system audits, and regulatory consulting. With a focus on innovation and efficiency, Intertek helps clients streamline processes, accelerate time to market, and enhance product performance. By leveraging their global presence and technical expertise, Intertek enables medical device companies to deliver safe and reliable products to patients worldwide.

• Medical Device Assurance Testing
• Bioanalytical Services
• Inspection

Europe, Middle East and Africa, and Asia-Pacific, North America, South America

In October 2019, Intertek Group plc had expanded the pharmaceutical services facility. The expansion was meant to expedite and deliver the clients contract manufacturing and outsourced biopharmaceutical and gene therapy development had recruited over 60 additional experts.

5.

Charles River Laboratories

Charles River Laboratories is a premier provider of research models and preclinical services to support drug discovery and development. Within the medical device outsourcing market, Charles River offers a range of specialized services, including biocompatibility testing, safety pharmacology studies, and toxicology assessments. With state-of-the-art facilities and experienced scientists, Charles River assists medical device manufacturers in evaluating product safety and efficacy, facilitating regulatory approval and market entry. Their comprehensive approach to preclinical testing helps clients mitigate risks, optimize development strategies, and accelerate the commercialization of innovative medical devices.

• Preclinical Medical Device Testing

North America, Europe, Asia-Pacific

In August 2003, Charles River Laboratories had launched the Endosafe-PTS. The Endosafe-PTS is a portable test system based on the Limulus Amebocyte Lysate (LAL) assay. The rise of the product launch had resulted in product expansion of pre medical device testing services in net sales.