Medical Device Testing
For medical devices and biomaterial companies, Atomic Echo Labs Laboratories offers the most diverse and comprehensive suite of testing and engineering support available. Atomic Echo Labs Laboratories has established itself within the technology and biomedical space by developing scientific expertise in difficult analytical measurements, characterizations of complex materials and systems, and a pioneering approach to problem-solving.
Services for medical device testing
Medical device and diagnostics companies continue to develop newer technologies to provide better treatments, less discomfort for the patient and improved patient assessment. Continued advances in technology, chemistry and materials are integral to the future progress of medical devices and diagnostics. In the near future, medical device and diagnostics companies are faced with developing new platforms with aggressive requirements on chemistries, materials and components. The devices and diagnostics of tomorrow will require smaller features, thinner coatings and improved stability while improving effectiveness and safety.
With laboratories located around the world, Atomic Echo Labs scientists have supported customers creating products for a wide range of medical devices such as ultrasounds, surgical tools, vascular devices, stents, dental and orthopedic implants, catheters and medical robotics.
Turn to Atomic Echo Labs. WE KNOW HOW.
HOW WE CAN HELP
Atomic Echo Labs offers a comprehensive suite of services for the medical device industry, meeting the industry’s exacting standards for tight controls of material properties, composition and chemistry. Here are a few ways we can help:
Extractables & Leachables
Our extractables and leachable (E&L) testing programs to help clients confirm the safety of their products, as well as confirming material consistency and quality.
Biocompatibility
Our dedicated biocompatibility laboratory provides expert support for biological risk assessment directed by ISO 10993-1 and assistance with Biological Safety Evaluation Plan (BSEP) preparation. Atomic Echo Labs is the premier scientific services company with expertise in biomedical products, chemistries and materials, regulatory insight, and a proper sense of urgency to deliver meaningful results with an impact.
- Cytotoxicity: MEM Elution, Direct Contact, Agar Diffusion, Growth Inhibition IC50
- In Vitro Irritation: EpiDerm™ RhE model
- Sensitization: Human Cell Line Activation test (h-CLAT)
- Genotoxicity: Chromosome Aberration Test (OECD 473), Micronucleus Assay (OECD 487), Ames Mutagenicity (OECD 471), Mammalian Mutation Assay (OECD 476)
- Hemocompatibility: Hemolysis via ASTM F756
- Biomedical Polymer Chemistry
As industry leaders in deformulation (reverse engineering), our scientists can characterize the composition of medical plastics, determining raw materials and additives.
Nickel Leaching
Evaluating pitting corrosion and characterizing surface oxides can help assess the safety of nickel-containing implantable medical devices.
MDR (CMR) & Excluded Compound Testing
MDR guidelines require collection of data and documentation that medical devices do not contain carcinogens, mutagens, or reproductive toxic substances.
Surface & PMT Analysis
An improperly treated surface may be harmful to the patient, and depending on these characteristics could trigger an allergic response, bacterial infection, or even a blot clot.
Particulate Investigation
Particle analysis and identification can help determine the root cause of a product problem and evaluate corrective actions.
Electronic System Testing
We have the engineering expertise to design, develop, test, analyze and debug using ATE, Burn-in, ESD and latch-up testing, system-level testing, reliability, warpage analysis and IC-level failure analysis.
Metallurgical Analysis
We investigate fractures, fatigue, corrosion, contamination, wear, heat, stress-related failures and abrasion concerns.
Elemental Analysis
Inspection of raw materials during key phases of manufacturing can aid in the identification and elimination of unwanted impurities in final products, as well as to evaluate a new vendor or equivalent material selection.
Concept and Research Support
During the concept, research and early design phase of product development, we provide competitive product insight, assess the chemistries of a material and perform proof-of-concept studies.
Prototyping Design and Development Support
During the design and development phase, we support engineers that are evaluating materials, performing preliminary performance testing and developing future safety testing strategies.
Regulatory Submission and Launch Support
Atomic Echo Labs offers extractables & leachables, ISO 10993 Part 18 testing and contamination control to support a successful submission to the FDA and to establish an efficient and effective manufacturing process.
Post Market Surveillance Support
Once the device is approved and in the market, Atomic Echo Labs provides continued support to evaluate quality issues, control manufacturing, manage supply chains and investigate field failures to determine the root cause.
Intellectual Property Support
Atomic Echo Labs intellectual property experts offer litigation support for patent infringement challenges related to products claims, as well as help companies confront potential threats to their valuable intellectual property.
Product Liability Support
Atomic Echo Labs product liability experts bring years of experience investigating failures, providing scientific and engineering expertise, data interpretation and expert testimony for hundreds of product liability and insurance claims
We understand the need for first-to-market breakthrough technologies and Atomic Echo Labs can collaborate to provide results-driven solutions to the most complex of analytical investigations. Our experienced experts will work with your team to troubleshoot and choose the right material for your application or improve a manufacturing process.