Medical Device Testing

Tentamus medical device laboratories support manufacturers and medical device companies during the development of their products. Our experts understand the needs and requirements of the industry and provide comprehensive service and quality through to market launch.

Medical device testing is governed by supra-product specific standards, technical specifications, or guidance documents.

Functionality testing for medical devices

• Structural cardiac, endovascular, vascular technologies, catheters, and guidewires
• Device functionality testing services (ISO 5840-1 / -2 / -3, ISO 5910, ISO 25539-1 / -2 / -3, ISO 7198, ISO 10555-1 / -2 / -3 / -4 / -5 / -6, ISO 11070)
• Silicone anatomical models and vessels
• Test systems for evaluating the functional performance and durability of devices
• Stent/Stent graft testing functionality testing (ASTM Standards)

Microbiological testing of medical devices

• Endotoxins and pyrogens: BEP / NEP testing (Ph. Eur. 2.6.14 / 2.6.30)
  • The classical LAL test (Ph. Eur. 2.6.14) is offered for the determination of endotoxins.
  • To detect other, non-bacterial pyrogens, the monocyte activation test (Ph. Eur. 2.6.30) is used.
• Bioburden determination & validation (ISO 11737-1)
• Microbiological performance qualification (ISO 11737-1/-2)
• Microbiological testing of products made of synthetic material
• Validation and testing of sterility using a Class A sterility test isolator (ISO 11737-2, ISO 11138)
• Stability studies

In vitro toxicology/biocompatibility of medical devices

• Dynamic and static hemocompatibility (ISO 10993-4)
  • Identification of complement activation and blood-damaging potential (including hemolysis, coagulation) of the medical device in an ex vivo experiment (human blood from volunteer donors)
• In vitro cytotoxicity and genotoxicity testing (ISO 10993-5 / <USP 87> /ISO 10993-3).
  • Cell culture-based determination of the cell-damaging potential of a medical device
  • Detection of heritable properties of the medical device
• Sample preparation & reference materials (ISO 10993-12)
• Skin irritation in vitro (ISO 10993-10)
  • Skin irritating and sensitizing potential of a medical device is tested in an in vitro skin model
• Skin sensitization and irritation of the ocular epithelium in vitro (OECD TG 442d/e /OECD TG 460/492)

Physical and chemical characterization of medical devices

• Resilience
• Chemical characterization (ISO 10993-18)
• Characterization of degradation products of different materials (ISO 10993-9 / -13 / -14 / -15)
• Durometry
• Integrity of the filter
• Calorimetry
• Photolysis
• Plastometry
• Testing of ethylene oxide sterilization residues (ISO 10993-7)
• Testing for extractable/soluble substances (ISO 10993-17)
  • Extractable and soluble substances (polar / non-polar) from the medical device are separated by chromatographic methods and analyzed semi-quantitatively by mass spectrometry
• Water absorption
• Spectrophotometry

Support of the development phase & know-how

• Preparation of necessary documents (incl. development documentation accompanying the project)
• Drafting of protocols for laboratory studies in compliance with regulatory requirements (e.g., FDA, ethics committees etc.)
• Support with regulatory issues and compliance
• Implementation of a development process according to ISO 13485
• Support of all tasks and decisions up to market access
• Clinical evaluation (e.g., Clinical Evaluation Plan - CEP or Clinical Evaluation Report - CER)
• Biological evaluation (e.g., Biological Evaluation Plan - BEP or Biological Evaluation Report - BER)

You want to bring your medical device to the market? Medical devices may only be placed on the market in the EU if they have a CE marking. This is only obtained if all safety and performance requirements are met.

These requirements vary according to the type and potential risk of the product. Furthermore, approval may also be granted only for a limited period or special approvals.

To meet the requirements for conformity of your medical devices, the products must undergo and pass various tests and inspections. Our team will be happy to create an individual test plan for your medical product. We support you in the conformity assessment process, including documentation, proofs, formulation of the intended use and assistance with the certification application, etc.

Our services for regulatory approval include:

• Establishment of QM systems (ISO 13485)
• Biocompatibility assessment
• Biological Evaluation Plan (BEP) / Report (BER)
• Classification analyses and delineation issues
• Clinical evaluations (CEP, CER)
• Conformity assessment procedures
• Clinical follow-up plan
• Biocompatibility / Biosafety testing
• Risk management
• Clinical Safety and Performance Summary (SSCP)

On May 26, 2021, the Medical Device Directive (MDD) was replaced by the new Medical Device Regulation (MDR). The MDR is intended to be an improved version of the MDD, with the main difference being that the MDR, as a regulation, requires direct implementation in all EU member states. This allows the MDR to create a uniform and fair regulation for all member states and raise standards for quality and safety measures.

Not only will the MDR extend to all EU member states, but the guidance it provides will also encourage companies to act and improve their current product hygiene and safety, which should significantly improve their overall standards.

The regulation's provisions require companies to review their portfolios and make the necessary changes to comply with the regulations.

We have listed the most important requirements here:

• Proof of a dedicated test plan according to DIN EN ISO 14155
• Proof of the safety of the product in question
• Approval of the competent higher federal authority BfArM (§ 22a MPG)
• Approval by the ethics committee
• Information and consent of the patient
• Conclusion of a proband insurance

In the United States, the FDA’s Center of Devices and Radiological Health (CDRH) is responsible for regulating medical devices created and sold in the United States.

Medical devices in the United States are defines by classes (I, II, and III). These classes determine what regulation requirements the device or technology is required to follow. All manufacturers and distributers must register with FDA between October 1st and December 31st. When you register your medical device you must list all companies involved with the creation of the product, this includes packagers, manufacturers, labelers, developers, and sterilizers.

Depending on which class your medical device is, you will be required to submit a premarket notification along with other regulations such as PMA review and a third party review.

In the United States, any incident where a medical device caused or contributed to the injury or death of a person is required to be reported to the FDA. Any and all malfunctions must be reported so that they may be corrected.

For medical devices to meet the specified standards and to ensure high quality, it is necessary to establish a quality management system in your own company.

Whether GMP, HACCP, or ISO - to keep an overview in the jungle of regulations and requirements, the medical device experts of the Tentamus Group support your company with the following quality management services:

• Conducting audits
• Development and implementation of QM systems (according to ISO 13485) or review of already established systems
• Practice-oriented training for your employees
• Assumption of responsible positions:
  • Quality Management Representative (QMB)
  • Responsible person (according to Art. 15 MDR)
  • (EU) Authorised Representative

The following laboratories from the Tentamus Group offer testing of medical devices: