Medical Device Safety and Efficacy Testing

From helping you understand regulatory requirements, through risk assessment and study design, to executing testing protocols with unparalleled quality and on-time results, Toxikon is ready to help you shepherd your medical devices through the approval process to get them to market quickly.

Ensuring the Safety and Efficacy of your Medical Devices

Medical devices have become powerful tools in improving the quality of life for patients worldwide. Consumers expect and deserve medical products that perform as expected, with minimal risk of adverse reactions.

The successful development of medical devices represents significant time, effort, and expense. Device failures negatively affect your reputation, your revenue, and most importantly, patient health. Are you completely confident that your device is safe and effective? Do you have concerns about successfully navigating the regulatory approval process?

It is important to partner with the right laboratory who will guide you from preclinical testing, through clinical trials, and ultimately to market. Preclinical medical device testing helps ensure that your device will pass regulatory approval easily: reducing your time-to-market, maximizing your investment, and paving the way to successful commercialization.

 

Medical Device Testing from Concept to Final Product

From helping you understand regulatory requirements, through risk assessment and study design, to executing testing protocols with unparalleled quality and on-time results, Toxikon is ready to help you shepherd your medical devices through the approval process to get them to market quickly.

With over 40 years of preclinical medical device testing success, Toxikon can be your trusted partner to help you reach your project goals for timely market launch.

 

Superior Quality and Accuracy

Toxikon is a preclinical contract research organization (CRO) accredited to ISO/IEC 17025 – an extensive set of standards confirming our competency as a testing laboratory. Our operations are governed by a rigorous quality management system, ensuring that you can trust the data we deliver in support of your products.

Additionally, we are registered with the United States Food and Drug Administration and the Japan Ministry of Health, Labor, and Welfare for drug and medical testing – and we have demonstrated success with working through these agencies to complete submissions and, when necessary, defend challenges.

 

Thought Leadership in Medical Device Testing Methods

As the both the variety of and complexity of medical devices increases, Toxikon is committed to staying at the forefront of medical device testing by continually evaluating our study methods and research techniques.

Our distinguished scientific staff not only fully understand medical device testing requirements; they help create them. Key Toxikon staff are contributors to the professional panels and organizations that define industry best practices and influence regulation and legislation.

The study directors, scientists, and technicians working on your device testing programs have access to the most current and effective methods available, executed under the supervision of industry-leading professionals. Our study directors understand the approval challenges that medical device developers face, and are well-positioned to help guide you through the dynamic regulatory landscape.

 

State-of-the-Art Device Testing Facilities

Whether it’s raw materials, components, or finished devices, Toxikon has the staff, methodology, and facilities to ensure best-in-class safety and efficacy testing. With over 125,000 square feet of advanced research space, Toxikon testing facilities include:

  • comprehensive laboratories with top-tier analytical instruments
  • accredited vivarium facilities for large and small species
  • modern surgical suites with state-of-the-art monitoring, imaging and measurement systems

Toxikon’s facilities are registered with the United States Food and Drug Administration and United States Department of Agriculture, and are accredited by American Association for Accreditation of Laboratory Animal Care. We also comply with the NIH’s Public Health Service Policy on Human Care and Use of Laboratory Animals, holding an assurance allowing for the execution of federally-funded studies.

 

Customized Programs to Meet your Unique Testing Needs

With the proliferation of advanced medical devices, drug delivery systems, reusable medical devices, and combination products that include pharmaceuticals or biologics, we offer a multidisciplinary approach to help you develop a customized risk assessment and testing methodology that proves safety and efficacy.

With a strong foundation in toxicology and biocompatibility, our custom device testing capabilities include:

  • ocular device and drug product development
  • proof of concept studies
  • surgical efficacy studies
  • comprehensive biocompatibility analysis
  • sterilization support
  • reusable medical device cleaning validation
  • combination product evaluations

With our breadth and depth of knowledge and experience in all facets of biocompatibility, analytical chemistry, and microbiology, Toxikon is prepared to design custom testing programs that will efficiently and effectively position your advanced devices for regulatory clearance.

 

Choose Toxikon for Medical Device Testing

Toxikon is a trusted partner for life science companies, providing the qualified, 3rd-party confidence that medical devices will perform as expected with minimal risk of adverse effects. Contact us today to discuss your product development needs and learn how we can support your testing requirements.

 

Medical Device Safety and Efficacy Testing
medical device testing, medical device efficacy, medical device safety, ISO 10993, medical device development, preclinical testing, preclinical contract research, contract research organization, CRO, quality, ISO 17025, analytical laboratory
Preclinical medical device testing helps ensure that your device will pass regulatory approval easily: reducing your time-to-market, maximizing your investment, and paving the way to successful commercialization. From helping you understand regulatory requirements, through risk assessment and study design, to executing testing protocols with unparalleled quality and on-time results, Toxikon is ready to help you shepherd your medical devices through the approval process to get them to market quickly.