Armoloy Accreditations
Armoloy Accreditations
What is NAMSA?
NAMSA (North American Science Associates) is a contract research organization (CRO) specializing in medical device testing, regulatory consulting, and clinical trial services. While it does not issue formal accreditations or certifications, it helps manufacturers verify compliance with ISO 10993-1 and other global safety standards.
NAMSA is the first independent lab for medical device testing. It specializes in biocompatibility assessments, chemical characterization, sterilization validation, and regulatory guidance. Its work helps manufacturers speed up product development, lower risks, and ensure medical devices meet strict safety standards before they hit the market.
NAMSA’s Core Principles
NAMSA focuses on advancing medical device safety through scientific integrity, regulatory expertise, and patient-centered testing. Their approach follows key principles that ensure medical technologies meet the highest standards before entering the market:
- Risk-Based Evaluation: Materials and devices are assessed based on intended use and patient exposure to ensure safety at every stage.
- Evidence-Driven Testing: NAMSA confirms accuracy and reliability by using scientifically validated methods, including ISO 10993-1 biocompatibility guidelines.
- Regulatory Alignment: Their processes align with global compliance standards, helping manufacturers navigate FDA, ISO, and MDR requirements efficiently.
- Comprehensive Lifecycle Support: From early-stage R&D to post-market surveillance, NAMSA provides expertise at every stage of a device’s lifecycle.
- Efficiency Without Compromise: By combining testing, consultation, and regulatory strategy, NAMSA accelerates time-to-market while maintaining strict safety standards.
These principles drive NAMSA’s mission to simplify compliance, reduce risk, and improve patient safety at every stage of development.
NAMSA Testing & Methodologies
NAMSA provides testing, consultation, and regulatory guidance to help medical device manufacturers meet ISO 10993-1, FDA regulations, and EU MDR requirements through key areas:
- Biocompatibility Testing: Conducts cytotoxicity, sensitization, and irritation tests to confirm materials are safe for patient contact.
- Chemical Characterization: Identifies extractables and leachables to evaluate potential long-term exposure risks.
- Sterilization Testing: Confirms coatings withstand sterilization techniques like autoclaving, EtO, and gamma irradiation without degrading.
- Wear and Corrosion Resistance: In addition to ISO 10993-1, NAMSA tests coating durability under stress, fluids, and repeated sterilization.
- Regulatory Compliance Support: Assists with FDA submissions, ISO 10993-1 compliance, and global approvals.
NAMSA testing confirms that medical devices meet global safety and compliance standards before market release.
Medical Device Applications That Rely on NAMSA
NAMSA’s testing services validate the safe use of coated components in medical devices. At Armoloy, coatings like BIO TDC® and ME-92®, for example, are tested for durability and biocompatibility across a wide range of applications, including:
- Surgical Instruments: Tested for biocompatibility, sterilization resistance, and wear resistance to withstand repeated use.
- Cardiovascular Devices: Stents, pacemakers, and implants require chemical characterization and toxicological risk assessments.
- Orthopedic Implants: Coatings on joint replacements, bone screws, and plates must resist corrosion and interact safely with human tissue.
- Dental & Maxillofacial Implants: Biocompatibility testing ensures materials are safe for long-term human contact.
- Diagnostic & Imaging Equipment: MRI and ultrasound probes require coatings that withstand frequent sterilization without degradation.
- Endoscopic & Laparoscopic Tools: Coatings must be low-friction, non-reflective, and biocompatible for minimally invasive procedures.
These applications highlight how NAMSA’s testing supports safe, compliant device development and coating performance across the medical industry.
Benefits of NAMSA-Tested Coatings
Proven Biocompatibility
Materials and coatings undergo ISO 10993-1 testing to confirm they are safe for human contact
Enhanced Durability
Coatings are validated for wear resistance, corrosion protection, and long-term reliability in medical environments
Sterilization Compatibility
Tested coatings withstand autoclaving, EtO, gamma irradiation, and repeated disinfection cycles without degradation
Regulatory Readiness
NAMSA testing simplifies compliance with FDA and ISO 10993-1 regulations
Reduced Risk of Failure
NAMSA testing helps prevent coating degradation, ensuring that medical devices perform reliably over time
Improved Device Performance
NAMSA-tested coatings reduce friction, improve edge retention, and prevent material breakdown
Streamlined Market Access
Validated coatings help manufacturers bring medical devices to market faster
Increased Trust and Credibility
Using coatings evaluated by NAMSA for biocompatibility demonstrates a commitment to patient safety and industry best practices
Accreditations at Armoloy
Armoloy follows NAMSA-tested methodologies to support compliance with ISO 10993-1 for medical device safety and performance. Contact us to find the right plating solution for your application.
Disclaimer: The interpretations and overviews of NAMSA guidelines provided by The Armoloy Corporation are solely the views of Armoloy and may not represent the views of other entities. These interpretations are intended for informational purposes only and should not be considered as definitive or legally binding. The Armoloy Corporation is not responsible for the accuracy of these interpretations and expressly disclaims any liability for loss or damage arising from their use. This disclaimer is subject to change and does not create any express or implied warranty regarding the information provided.