Eurofins Medical Device Testing

From raw materials to finished products, chemical characterisation is critical to identifying and quantifying the chemical constituents of materials used throughout the development process.

With more than 500 state-of-the art chromatographic analyzers and 200,000 cubic feet of environmental chambers, operated by our global team of highly trained chemists and PhDs, Eurofins Medical Device Testing is an ISO 17025 accredited laboratory providing unparalleled capabilities for all your physiochemical testing needs.

Choose Eurofins Medical Device Testing to help you:

• Confirm the purity of raw materials
• Characterize the degradation and dissolution of resorbable polymer devices or bone ingrowth coatings
• Ensure the safety profiles of processing aid additives used in plastic devices
• Assess the impacts of changes to raw material suppliers
• Assess the impacts of changes to raw material suppliers, processing techniques or sterilization methods
• Perform early stage developmental testing of new formulation and product design
• Ensure products are free of processing contaminants and residuals, such as machining oils and cutting fluids

• Extractable and Leachables
• Particle Size Identification
• Unaxial mechanical Testing
• Dissolution
• Material and product stability
• Raw material purity
• Residual Ethylene Oxide

Whether validating terminal sterilisation processes, or evaluating methods for cleaning and reprocessing reusable devices, Eurofins Medical Device Testing helps clients fulfill the stringent microbiological and sterility testing requirements needed for medical devices.

As an ISO 17025 accredited laboratory with more than 68,000 ft2 of micro laboratory space, including six sterility suites, our team of highly skilled experts operate the most advanced microbial identification equipment.

Choose Eurofins Medical Device Testing to help you:

• Validate the sterilisation of your terminally sterilised devices
• Conduct routine sterility testing for batch release testing or quarterly dose audits
• Validate cleaning and reprocessing procedures for reusable devices and instruments
• Evaluate water quality and/or environmental monitoring for your clean room operations
• Conduct routine endotoxin, bioburden and bacterial identification
• Assess the effectiveness of your antimicrobial device

• Sterility Testing and Sterility Validation
• Antimicrobials/Infection Control
• Bioburden Testing
• Reprocessing Validations
  
• Bacterial Endotoxin Testing (LAL)
• Bacterial Identification
• Water Testing

In addition to validating the design and functionality of your medical device, there are a myriad of testing requirements needed to ensure your product reaches the end user intact. From primary seal testing through pallet-level transit testing, our state-of-the-art package testing facility provides complete capabilities for evaluating every aspect of your package and labeling configurations, to ensure your product will survive the rigors of being transported around the world.

Choose Eurofins Medical Device Testing to help you:

• Validate your shipping configurations will withstand the rigors of global transit
• Assess your packaging design and material selections
• Ensure the integrity of your product’s primary sterile barrier
• Confirm your labels conform to UDI regulations and remain readable through your entire distribution channel

Sterile Barrier/Seal Integrity Testing:

• Dye Penetration
• High Voltage Leak Detection (HVLD)
• Bacterial Immersion
• Oxygen Headspace
• Vacuum Decay

Distribution Testing:

• Transit Testing
• Package Drop Testing
• Stacked Box Crush Testing
• Label Durability Testing
• Sutherland Rub
• UDI Readability

Whether validating terminal sterilisation processes, or evaluating methods for cleaning and reprocessing reusable devices, Eurofins Medical Device Testing helps clients fulfill the stringent microbiological and sterility testing requirements needed for medical devices.

As an ISO 17025 accredited laboratory with more than 68,000 ft2 of micro laboratory space, including six sterility suites, our team of highly skilled experts operate the most advanced microbial identification equipment.

Choose Eurofins Medical Device Testing to help you:

• Validate the sterilisation of your terminally sterilised devices
• Conduct routine sterility testing for batch release testing or quarterly dose audits
• Validate cleaning and reprocessing procedures for reusable devices and instruments
• Evaluate water quality and/or environmental monitoring for your clean room operations
• Conduct routine endotoxin, bioburden and bacterial identification
• Assess the effectiveness of your antimicrobial device

Biocompatibility testing is a critical part of the regulatory approval process for medical devices as even the best designed products can produce unintended complications if the materials used cause a biological reaction in the patient. Well characterised materials widely used in the industry can produce unexpected reactions if processed in a way that leads to contamination, degradation, or leaching of toxic compounds into a patient.

Eurofins Medical Device Testing is ISO 17025 accredited and has expertise in a wide range of products and manufacturing processes to help assess the risks of a new device design or process change, and develop an appropriate testing program for assessing the safety of your products.

From chemical characterisation of degradation products and extractables and leachables testing, to toxicological risk assessments and biological evaluations, our veterinarians, chemists, and toxicologists can facilitate the appropriate testing to best support your international regulatory submissions. 

Choose Eurofins Medical Device Testing to help you:

• Evaluate the biocompatibility of your new device
• Assess the impact of a design change or new manufacturing process on your device’s safety
• Evaluate new raw material suppliers
• Consider effects of sterilization techniques or long-term material stability
• Generate toxicology reports
• Review the biocompatibility evaluations for your international regulatory submissions
• Establish biological safety plans and conduct gap analyses of existing biocompatibility dossiers

 Biocompatibility Testing: 

Chemical Characterisation:

• Extractable and Leachable Testing
• Degradation Products
• Residual Ethylene Oxide

Toxicology:

• Toxicological Risk Assessments
• Genetic Toxicology
• Alternative Toxicology

In Vitro Biocompatibility Testing:

• Cytotoxicity
• Hemocompatibility 
• Genotoxicity
• Developmental and Reproductive Toxicity

In Vivo Biocompatibility Testing:

• Sensitisation
• Irritation
• Hemocompatibility
• Genotoxicity
• Subchronic/Chronic Toxicity
• Systemic Toxicity
• Implantation
• Developmental Reproductive Toxicity

The process of bringing together bio/pharmaceuticals and medical devices to create a combination product requires specific testing on all product constituents. Eurofins Medical Device testing is well versed in the vast testing requirements and regulatory guidelines for bio/pharmaceutical products, as well as medical devices and offers comprehensive testing services for these components, both individually and combined.

From prefilled syringes, to drug coated implants and cell seeded scaffolds, our expertise covers the full range of testing needs for virtually any type of combination product.

Choose Eurofins Medical Device Testing to help you:

• Assess the chemical interactions among the constituents of your combination product
• Determine cellular viability and long-term stability of your product under a range of environmental conditions

Combination Product Testing:

• Drug Release and Dissolution Testing
• Chemical compatibility Testing
• Stability Testing
• Container Closure Integrity Testing (CCIT)
• Syringe Testing 

Worldwide medical electrical equipment and in vitro diagnostic medical devices are controlled by strictly regulated National and international approval procedures which include testing, certification and audit requirements.

Both current and upcoming regulations place a focus on evaluating and reducing the risks involved with Medical Devices and their connections to other devices and/or IT networks.

Eurofins Medical Device Testing and certification services can help you ensure compliance with the latest standards and regulations, while achieving Global Market Access (GMA) in a cost and time efficient manner.

Choose Eurofins Medical Device Testing to help you:

• Check basic safety and essential performances
• Achieve compliance with the Medical Device Directive (MDD) 93/42/EEC
• Achieve compliance with the In Vitro Diagnostic Medical Devices Directive (IVDD) 98/79/EC  
• Ensure conformity to IEC 60601 & IEC 61010 standards*
• Obtain CB Scheme test reports and certificates
• Achieve ISO 13485
• Gain global Market access; including Europe (CE Mark) & US (Eurofins NRTL MET Mark) & Canada (SCC accreditation certification)
• Ensure your Medical Device is Secure

*Where IEC standards are referred to, national and regional variations are also applicable including, but not limited to; ANSI/AAMI, UL, ISO, CAN/CSA, JIS, EN, ENV, BS EN, DD ENV and BS IEC. Please enquire on a case by case basis.

Medical Electrical Equipment Testing:

• Safety and Performance Testing
• Certification Services
• Medical Device Security

Electronic medical devices and healthcare systems represent a growing risk to patients, hospitals and medical centers. The threat is not only to sensitive data, but to lives as well. Health care organizations have 300%-400% more medical equipment than other IT devices, and as a result, security and management can become overwhelming. Ensuring these devices are secured and managed properly is of critical importance.

Securing medical devices begins in the design phase and should be considered throughout the system development lifecycle. Ensuring proper controls are in place and identifying vulnerabilities should be central to the System Development Lifecycle methodology.

Eurofins Medical Device Testing has been a global leader in standards testing, QA testing, cybersecurity testing, and digital testing for decades. We use our expertise to help medical device manufacturers around the world secure products before, during, and after-market release.

Eurofins Medical Device Testing offers a full array of cyber security services to ensure medical devices meet the highest standards for security and align our testing with UL2900, which is recognised by international bodies as a sound security standard for medical and other connected devices.

By partnering with Eurofins Medical Device Testing and leveraging our world-class security testing services, you will greatly improve your product’s security posture and ensure your customers and their patients are protected.

Choose Eurofins Medical Device Testing to help you:

•    Secure designs and architectures.
•    Provide adequate documentation and operational guides.
•    Provide sufficient security controls.
•    Ensure proper auditing, logging and alerting.
•    Provide robust identity and access management.
•    Provide vulnerability identification, documentation, remediation, and mitigation.
•    Ensure application security.
•    Validate security through penetration testing.

Whether you are in the design phase, or have had products in production for years, Eurofins Medical Device Testing can help secure and protect your medical devices to position you ahead of the competition.

Eurofins Medical Device Testing offers a full array of Security Assessment Services including comprehensive portfolio options to meet all your business security needs. These services are aimed at baselining your security posture and identifying vulnerabilities and threats. We take a risk-based approach considering likelihood of exploitation and business impact, so you can manage your remediation efforts in a way that aligns with your business priorities.

What do we assess for?

Eurofins Medical Device Testing will review your organization, systems, applications, and data for:

Our Risk Assessments are designed to meet your specific business needs. We customize each assessment to align with unique business, security, compliance and budgetary requirements. Our assessments can include any combination of the following phases, which can be combined for larger projects or delivered individually.

Governance Gap Assessment

A review of standards, policies, processes and all aspects of an organisation’s SDLC and security programs.

Compliance Gap Assessment

A review of specific regulatory compliance requirements as they relate to device design and manufacturing.

Vulnerability Assessment

A review of device security, with the goal of finding vulnerabilities and security weaknesses.

Web Application Security Assessment

A review of device web applications with a focus on coding and configuration errors. Code review services to identify vulnerabilities and coding errors that leave the application susceptible to attack.

Remote Security Assessment

An assessment of all remote access mechanisms which are thoroughly reviewed for vulnerabilities, best practices, encryption, authentication, monitoring, design and management.

Penetration Testing

Exploitation of vulnerabilities found with escalation of privilege and lateral movement throughout the enterprise. This simulates a real-world attack and tests the efficacy of existing controls and exploitation of vulnerabilities.

Wireless Security Assessment

A review of wireless architectures, configurations and controls. We will assess authentication, encryption, monitoring, configuration, management, and much more

In order to gain regulatory authority approvals to place medical devices on the market, equipment manufacturers must prove their products comply technically and administratively with relevant standards and gain the necessary certifications.

Different global regions and countries have different regulatory and certification requirements and gaining them can prove costly and time consuming. Eurofins Medical Device Testing’s certification services can help you earn the certifications needed to bring your Medical Devices to market .

Choose Eurofins Medical Device Testing to help you obtain:

• Access Global Markets efficiently and easily
• Gain access to Europe through our Notified Body services
• Gain access to the US through Eurofins MET labs NRTL services and FDA expert services
• Gain access to Canada through Eurofins MET labs SCC services
• Certify your product through the CB Scheme for compliance in over 50 countries

When it comes to understanding the physical structure, chemical properties and composition of materials, no other scientific services company offers the breadth of experience, diversity of analytical techniques or technical ingenuity of Eurofins Medical Device Testing. We don’t just perform testing, we drive commercial success—through thoughtfully designed investigations, technically superior analyses and expert interpretation of data.

Our laboratories are equipped with state-of-the-art instrumentation for material and chemical characterization:

• Spectroscopy: FTIR, NMR, Raman, UV-Vis
• Chromatography: GC, LC, GPC, IC
• Mass Spectrometry: LC/MS, GC/MS, Pyrolysis GC/MS, MALDI
• Thermal: DSC, DTA, TGA, TMA, DMA, Rheology, Viscometry, Dilatometry, HALT/MEOST
• Elemental: GDMS, ICP, XRF, EDS
• Microscopy: SEM, TEM, FIB, AFM, OP
• Surface: XPS/ESCA, TOF-SIMS, Auger
• Structural/crystallographic: XRD, XRR, EBSD

Choose Eurofins Medical Device Testing to help you customize chemical analyses involving:

•    Surface Analysis
•    Compositional Analysis & Material Identification
•    Contaminant Identification
•    Trace Elemental Analysis
•    Advanced Microscopy
•    Failure Analysis
•    Deformulation & Reverse Engineering
•    Metallurgical Analysis
•    Polymer Characterization
•    Custom Synthesis
•    Litigation Support

Materials and Chemical Characterisation Testing:

• Metallurgical Engineering and Characterisation
• Microscopy and Morphological Characterisation
• Polymer Chemistry
• Surface Analysis