By Thaddeus Williams, D.V.M., Study Director of In-Vivo Biocompatibility, Toxikon Corporation Introduction When developing a preclinical testing plan for medical devices, selecting the correct extraction solvents can be confusing. Incompatibility between solvent and device may result in an extract that is unusable or harmful to the test system. A Solvent Compatibility Test can make the […]
Toxikon
6 exhibitors at DeviceTalks West you should know
DeviceTalks West is an annual event that allows some of the best minds in medtech to exchange ideas, insights and technologies. Medical Design & Outsourcing’s parent company WTWH Media holds DeviceTalks annually in Boston, Orange County, Calif., and the Twin Cities in Minnesota. It is hosted by MassDevice and attendees can plan to enjoy networking with people in […]
Nelson Labs parent Sterigenics buys Toxikon’s European lab business
Sterigentics International is seeking to turn its Nelson Labs business into a global extractables and leachables lab testing platform through its acquisition of Toxikon’s European division. The purchase of Toxikon Europe, announced yesterday, represents a capabilities expansion when it comes to serving the pharmaceutical and medical device industries. Sterigenics’s Nelson Labs business will now offer Toxikon […]
Five DeviceTalks Boston exhibitors you should know
DeviceTalks Boston is an annual event that allows some of the best minds in medtech to exchange ideas, insights and technologies. The event is hosted by MassDevice. Those who attend the event can expect to network with other medtech enthusiasts, attend in-depth interviews with leaders in the industry and panel discussions about medical devices and […]
Understanding the Changes to USP 661
By Stephen Doherty and Amtul Qamar Confused about the revisions to USP <661>? We can help. In May 2016, the revision of USP General Chapter <661> with the new title “Plastic Packaging Systems and Their Material of Construction” took effect. The revision represents a major change in the testing strategies related to plastic container systems. […]
Outsourcing Bioskills Workshops To Contract Research Organizations
Medical device companies frequently need to conduct bioskills training events either to educate their sales force on new devices/technology, to educate new hires to the sales force, or to provide hands-on experience to the surgeons who may be using their devices. This is especially true for companies manufacturing products used in interventional cardiovascular procedures and […]
FDA Finalizes Guidance On Medical Device Safety Evaluation
On June 16, FDA finalized a guideline of broad significance for the medical device industry, Use of International Standard ISO 10993, ‘Biological Evaluation of Medical Devices Part 1: Evaluation and testing within a risk management process’. This guidance was published in draft form in April 2013 and the medical device community has therefore been aware […]
Narrative of New ISO 10993-1 Standard – Part 1: “Evaluation and testing within a risk management process”
By Laurence Lister, Department Head, Biocompatibility Services The big topic in biocompatibility this year is the release of the much anticipated final version of, “Use of International Standard ISO 10993-1, ‘Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process’”, from the FDA. The draft was issued in April […]
Biocompatibility explained: A simple understanding to a complex topic
Medical Grade Qualification Class VI Regulatory Requirements Biocompatibility Defined ISO 10993 Testing Test Strategy Determination Sample Preparation Test Category Descriptions & Assays Case Study Conclusion
Combination products: Safety and efficacy considerations of device/drug/biologic interactions
A presentation on Combination Products, which includes the following: Combination Products Definition FDA Guidance for Industry Case Study 1 – Insulin Delivery System Case Study 2 – Antimicrobial Eluting Catheter Technical Risk Assessment Be on the lookout for the video presentation coming shortly.
Medical device testing guide
A resource for sample submissions, test descriptions, sample requirements, and turnaround times for biocompatibility testing according to: FDA/ISO 10993 MHLW-Japan USP AAMI