How do we support you during the development of medical devices?

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.

Tentamus Group offers an accred­ited testing plat­form for your medical devices so you can ensure your prod­ucts are both func­tional and safe for market.

What tests are used
to test medical devices?

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)
Do you need assistance?

Please do not hesi­tate to contact our team. We will be happy to advise you via live chat or email to pharma@​tentamus.​com

Medical Device Certification Consulting

How do we support you with medical device certification

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.

For the scien­tif­i­cally vali­dated assess­ment of your prod­ucts, we prepare mean­ingful clin­ical and medical reports and tech­nical documentation.

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)

Regulatory requirements
for medical devices

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.

Medical devices are subject to several regu­la­tory require­ments to protect the health of users, patients and third parties.

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.

Quality management
for medical devices by Tentamus

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

Overview of
laboratories for the testing of medical devices

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

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