Biocompatibility and Toxicology

Interactive Submission Process

PSN Labs is a full-service development partner, focusing on biocompatibility in medical device manufacturing. Hear from our experts as they discuss the current trends and future of bio-c in this seven part series.

AIIN Clock/Regulatory Body Submission Changes

PSN Labs bridges the gap between the FDA and medical device manufacturers to stay on top of regulatory changes and help in your 510(k) Clearance Submissions.

Cleaning and Disinfection of Medical Devices

One often overlooked, yet extremely important, topic in the medical device industry, is the effect of commercial grade cleaning chemicals on the materials of construction, and the effect this process has on patients. This is a conversation that needs to be brought to the forefront of the design process and evaluated in the overall testing of a device.

Materials of Construction for Medical Devices

Materials of construction make a huge difference in the biocompatibility of medical devices. Just because a material was used 30 years ago, does not guarantee it is safe for patients today. Find out how PSN Labs can test your devices to ensure patient safety.

Bioaccumulation

The hot new topic of the FDA submission process is the concept of bioaccumulation. Find out how to ensure your device is safe and see how we can assist in your manufacturing processes and materials of construction to ensure your device is safe for patients.

Material Selection

When it comes to material science, PSN Labs is the leading expert. From design to prototype to testing and eventually full-scale production, we cover it all to ensure your device is safe for patients and ready for regulatory body submissions. PSN Labs is your full-service development partner.

Design for Biocompatibility

We assist medical device manufacturers with the process of launching a new product or reviewing/modifying an existing product through each phase of the process from design to functional prototypes to testing and full-scale production. We are the leading biocompatibility experts in the industry with a full team of toxicologists, material scientists, and engineers on staff.

We work with the FDA to stay on the forefront of regulatory challenges to assist in 510(k) submissions and ensure patient safety is a top priority.

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Biocompatibility and Toxicology

We solve your toughest design, material, and manufacturing challenges.

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Certifications

ANAB Cert
Perry Johnson Cert
PJLA
ISO 13485