Medical Devices.

Helping you enter the European, Asian, and North American markets effortlessly

As a medical device manufacturer, you are required to provide a technical file that demonstrates your product meets EU safety and performance requirements.

This file must be submitted to a Notified Body for approval.

This file is a mandatory step in acquiring the CE Marking, an EU health, safety, and environmental certification that allows products to be marketed in 32 countries.

Toxi Plan is your trusted partner in satisfying one of the most important steps —> Toxicology documentation demonstrating compliance with biological safety requirements.

The Regulatory MDR Technical File.

All medical devices entering the EU market require a Technical File. This file provides information about the design, manufacturing, and operation of your medical device. It is intended to demonstrate that your device conforms to regulatory requirements.

Our Services.

Toxi Plan offers customizable toxicology, eco-toxicology and regulatory services to meet your market entry and sustainability needs.

Eco-Toxicology

(add-on services)

Toxicology & Regulatory

  • Toxi Plan offers regulatory consulting services to help you establish a robust BEP. We help identify the specific tests your device needs to ensure its biocompatibility, in accordance with the ISO 10993-1 standard.

    This cost-saving customized report will help you optimize your time and budget!

  • Toxi Plan carries out literature reviews on similar medical devices and on the history of use of your medical device’s materials, in accordance with the ISO 10993-1:2020 standard.

  • If not available from suppliers, Toxi Plan will prepare the toxicological profiles of the materials used in your medical device.

  • In the event of a material shortage or multisourcing challenge, Toxi Plan will provide a study of alternative materials, equivalent to the original.

  • Toxi Plan will help you establish your device’s chemical characterization protocol, defining the various analytical parameters (extraction protocols, toxicological thresholds, etc.), in accordance with ISO 10993-12 and 18 standards.

    We provide support through each stage of the chemical characterization process through our partnerships with accredited and reliable laboratories.

    **To Note: CCs and BCs should not be performed by Toxi Plan to avoid conflicts of interest as is mandated by local law, Notified Bodies and the Medical Device Regulation (EU) 2017/245.

  • Toxi Plan will analyze and provide a report on the toxicological acceptability of extractives found during the Chemical Characterization (CC) of your medical device, in accordance with the ISO 10993-17 standard.

  • Our company is committed to adhere to the highest ethical standards. For that reason, Biocompatibility Tests (BC) are conducted via external and independent labs. BCs are performed in accordance with the ISO 10993 set of standards.

    We are happy to provide you with a list of referrals.

    **CCs and BCs should not be performed by Toxi Plan to avoid conflicts of interest as is mandated by local law, Notified Bodies and the Medical Device Regulation (EU) 2017/245.

  • Toxi Plan will provide you with a thorough analysis and interpretation of your BC results, in according with the ISO 10993 set of standards.

  • Toxi Plan evaluates the presence of physical, chemical and microbiological contaminants your medical device.

    The process of validating cleaning procedures is in accordance with the ISO 19227:2018 standard.

  • Toxi Plan provides a thorough BRA to be included into your regulatory file. Some of the elements include in the report:

    • Toxicological profiles of materials in direct or indirect contact with the patient. It includes review of toxicological data available in the scientific literature;

    • Review of the scientific literature on similar devices already on the market, to analyze the experience of use;

    • Interpretation of biocompatibility test results to ensure compliance.

An evolving regulatory landscape and a growing push toward environmental stewardship in healthcare calls for a shift to more sustainable manufacturing.

Future-proof your success. Check out our eco-toxicology add-ons.

1. An Eco-Toxicological Profile

2. Eco-Toxicity Testing

3. An Eco-Toxicological Impact Assessment

Medical Devices is one of our fastest growing business sectors!

  • Orthopedic surgery equipment, intubation probes, in vitro diagnostic equipment, syringes, catheters, cardiac stents, stethoscopes, etc.

  • Including intracranial implants

  • Injection/self-injection devices

  • Dental gels, toothpaste, contact lenses, contact lens care product solutions, etc.

  • External breast prosthesis, contoured protectors, etc.

  • Pain-relieving gels, nasal and ear sprays, etc.

  • Wound dressings, bandages, absorbable sutures, antiseptics

  • Surgical masks, surgical gloves, etc.

  • Dermal filler, suspension threads

  • Tampons, sanitary napkins or pads, panty liners

Spotlight

Our toxicologists have assessed the toxicological and biological risks of numerous devices.

Get the lowdown on our services - download our brochure for easy access anytime!

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