Medical Device Testing
Arterex Medical provides end-to-end medical device testing services — from early-stage design validation to final regulatory submission — helping manufacturers bring safe, compliant devices to market faster.
We cover every critical testing domain: biocompatibility, electrical safety, sterilization validation, software and cybersecurity, usability, performance, packaging integrity, and clinical risk management. Every test is conducted in our ISO 17025-accredited laboratory under an ISO 13485-certified quality management system, producing data accepted by FDA, notified bodies, and health authorities across every major global market.
Our process is structured from the first consultation to the final submission. We review your device, map it to the exact regulatory standards it must satisfy, and build a formal test plan before a single sample is prepared. Testing is conducted by qualified engineers following validated protocols, with all data recorded in real time and interpreted against defined acceptance criteria. Every completed test generates a submission-ready report structured for direct inclusion in a 510(k), PMA, MDR technical file, or De Novo submission.
What separates Arterex Medical from a generic testing lab is regulatory depth. Our engineers specialize in specific device categories — active implantables, in vitro diagnostics, combination products, SaMD, and sterile single-use devices. Our regulatory affairs team supports submission assembly, gap analysis, and agency query response. Our certifications span every standard your device will be evaluated against, including ISO 10993, IEC 60601-1, IEC 62304, ISO 14971, and ISO 11607.
Whether you are validating a first-generation prototype or maintaining compliance for a device already on the market, Arterex Medical has the accreditation, expertise, and process to support you at every stage.
What Medical Device Testing Services Do We Offer?
We provide end-to-end medical device testing services, covering everything from early-stage design validation to final regulatory submission. Every test we conduct is built around one goal: getting your device to market safely, compliantly, and on time.
Biocompatibility Testing
Medical devices must demonstrate safety at the biological level before any clinical use. We conduct biocompatibility testing in accordance with ISO 10993, evaluating cytotoxicity, sensitization, irritation, systemic toxicity, and implantation response. Whether your device is skin-contact, mucosal, or implantable, we determine the correct test endpoints based on device category and duration of contact.
Electrical Safety & EMC Testing
Electrical medical devices must meet IEC 60601-1 safety standards and pass electromagnetic compatibility (EMC) testing before market entry. We test for dielectric strength, leakage current, protective earth resistance, and immunity to electromagnetic interference. Our lab covers both conducted and radiated emissions to satisfy FDA, CE, and international market requirements.
Sterilization Validation
Sterilization processes must be validated to confirm consistent and effective microbial reduction across every production batch. We support validation for EO (ethylene oxide), gamma irradiation, electron beam, steam autoclave, and dry heat sterilization methods. Testing follows ISO 11135, ISO 11137, and ISO 17665 as applicable to your chosen sterilization modality.
Software & Cybersecurity Testing (SaMD)
Software as a Medical Device (SaMD) requires risk-based verification, validation, and cybersecurity assessment under IEC 62304 and FDA guidance. We test software functionality, usability, data integrity, and vulnerability to cyber threats. This is especially critical for connected devices, cloud-based diagnostics, and AI-driven medical software.
Usability & Human Factors Testing
Poor device usability causes use errors that directly harm patients. We conduct formative and summative usability evaluations in line with IEC 62366-1 and FDA’s Human Factors guidance. Testing identifies use errors, near misses, and critical task failures before your device reaches clinical environments.
Performance & Functional Testing
Devices must perform within defined specifications across their intended use conditions and lifecycle. We conduct functional performance testing, durability testing, fatigue testing, and accelerated aging studies. Testing environments simulate real-world conditions including temperature, humidity, mechanical stress, and fluid exposure to validate that performance holds across the full product lifecycle.
Sterile Barrier & Packaging Integrity Testing
Packaging protects sterility from point of manufacture to point of use. We validate sterile barrier systems per ASTM F2097 and ISO 11607, including seal integrity testing, accelerated and real-time aging, and distribution simulation. Packaging failure at any point in the supply chain creates a direct patient safety risk.
Clinical Evaluation & Risk Management Support
Clinical evidence supports regulatory submissions and demonstrates device safety and performance in clinical use. We assist with clinical evaluation reports (CERs), risk management documentation per ISO 14971, and post-market clinical follow-up (PMCF) planning. Our team aligns every document with MDR, FDA 510(k), PMA, and De Novo pathways as needed.
What is Our Process for Medical Device Testing?
Medical device testing is not a single step — it is a structured sequence of actions, each one building on the last. Our process is designed to eliminate gaps, reduce rework, and produce documentation that holds up under regulatory scrutiny.
Step 1: Initial Consultation and Device Review
Every engagement starts with a detailed review of your device, its intended use, and its target markets. We assess device classification, material composition, intended patient contact, and applicable regulatory pathways. This step defines the full scope of testing required before a single test begins.
Step 2: Regulatory Pathway Mapping
We identify every applicable standard and regulation your device must satisfy — FDA, MDR, PMDA, Health Canada, or others depending on your target markets. Each standard is mapped to a specific test protocol, so nothing is missed and nothing is duplicated. You receive a complete testing roadmap with timelines and deliverables before work begins.
Step 3: Test Plan Development
Our engineers develop a formal test plan that documents the scope, methodology, acceptance criteria, and sequence for every required test. The test plan follows ISO 13485 quality system requirements and serves as the master reference for the entire testing program. Any changes to device design or claims trigger a test plan revision before testing proceeds.
Step 4: Sample Submission and Preparation
You submit device samples according to our defined submission requirements for each test type. Samples are logged, inspected, and prepared under controlled conditions to prevent contamination, damage, or traceability gaps. Chain of custody is maintained throughout to satisfy auditor and regulatory expectations.
Step 5: Testing and Data Collection
Testing is conducted by qualified engineers in accredited laboratory conditions. Every test follows a validated protocol, and all raw data is recorded in real time with no post-hoc modifications. We run biocompatibility, electrical safety, sterilization validation, performance, usability, and packaging tests in a sequenced order that minimizes delays between dependent test phases.
Step 6: Data Analysis and Interpretation
Raw test data means nothing without proper interpretation against defined acceptance criteria. Our team analyzes results against the relevant standard, flags any out-of-specification findings, and determines whether the device passes, requires retesting, or needs design correction. We do not pass ambiguous results — every finding is documented with a clear disposition.
Step 7: Regulatory Documentation and Reporting
Each completed test generates a formal test report structured for direct inclusion in a technical file, 510(k), PMA, or MDR dossier. Reports include test objectives, methodology, equipment used, raw data, results, and a regulatory compliance statement. Our documentation is written to answer the questions a regulatory reviewer will ask, not just to satisfy internal records.
Step 8: Regulatory Submission Support
If you need support beyond testing, our regulatory affairs team assists with submission package assembly, gap analysis, and response to agency queries. We have experience supporting FDA pre-submission meetings, notified body audits, and technical file reviews. When questions arise post-submission, we provide the technical backup to respond quickly and accurately.
Step 9: Post-Market and Ongoing Compliance
Regulatory approval is not the end of your compliance obligations. We support post-market surveillance testing, periodic safety update reports (PSURs), PMCF studies, and retesting triggered by design changes or field complaints. Your device stays compliant as regulations evolve and your product matures.
Why Choose Arterex Medical for Medical Device Testing Services?
Choosing a testing partner is one of the most consequential decisions in your device development cycle. The wrong partner creates delays, documentation gaps, and failed submissions. Arterex Medical exists to make sure none of that happens.
1. Regulatory Knowledge Across Every Major Market
Arterex Medical has direct working knowledge of FDA, MDR, PMDA, Health Canada, and TGA requirements. We map your device to the exact standards it needs to meet in each target market — preventing over-testing, under-testing, and the costly gaps that surface late in the submission process.
2. Accredited Laboratory, Audit-Ready Documentation
Every test is performed in an ISO 17025-accredited laboratory under an ISO 13485-compliant quality management system. Our equipment is calibrated, our methods are validated, and our reports are structured to survive regulatory scrutiny at any point. When an FDA reviewer or notified body auditor examines your data, there are no credibility questions.
3. Full Device Lifecycle Coverage
Arterex Medical covers your device from design validation through post-market surveillance — biocompatibility, electrical safety, sterilization validation, software testing, packaging integrity, and beyond. Your testing history stays in one place, your documentation stays consistent, and you never re-explain your device to a new lab at every phase.
4. Device-Type Specialists, Not Generalists
Our engineers hold deep specialization in active implantable devices, in vitro diagnostics, combination products, SaMD, and sterile single-use devices. You work with someone who has tested devices in your category before — not someone learning your regulatory domain on your timeline.
5. Faster Time to Market Without Compliance Risk
Our sequenced testing protocols, pre-built regulatory templates, and in-house regulatory affairs support are built to compress timelines without introducing risk. Clients who come to Arterex Medical after delays elsewhere consistently reach submission faster on their second attempt than they did on their first.
6. Submission-Ready Reports, Every Time
Every Arterex Medical test report is structured for direct inclusion in a 510(k), PMA, technical file, or MDR dossier — no reformatting required. Our documentation answers the questions a regulatory reviewer will ask before they ask them, reducing deficiencies and accelerating approval.
Our Certifications for Medical Device Testing
Every test result is only as credible as the system behind it. Our certifications confirm that Arterex Medical’s testing data is technically sound, regulatory-compliant, and accepted by health authorities worldwide.
ISO 17025 — Testing and Calibration Laboratory Accreditation
Arterex Medical holds ISO 17025 accreditation, confirming our laboratory operates with validated methods, calibrated equipment, and technical competence recognized by FDA and international regulatory bodies.
ISO 13485 — Medical Device Quality Management System
We are ISO 13485 certified, meaning every process from sample intake to report issuance operates within a quality management system built specifically for medical device testing environments.
ISO 10993 — Biological Evaluation of Medical Devices
Arterex Medical is qualified to conduct the full ISO 10993 series, including cytotoxicity, sensitization, irritation, systemic toxicity, and genotoxicity testing for all patient-contacting device categories.
IEC 60601-1 — Electrical Safety for Medical Equipment
We conduct full IEC 60601-1 third edition testing, covering dielectric strength, leakage current, and protective earth resistance for powered medical devices entering US, EU, and global markets.
IEC 62304 — Medical Device Software Lifecycle
Arterex Medical is qualified to assess IEC 62304 conformance across all software safety classes, supporting verification and validation for SaMD and embedded medical device software submissions.
IEC 62366-1 — Usability Engineering
We conduct formative and summative usability evaluations in full conformance with IEC 62366-1, satisfying FDA Human Factors requirements for device submissions targeting the US and EU markets.
ISO 11135 / ISO 11137 / ISO 17665 — Sterilization Validation
Arterex Medical validates EO, gamma, electron beam, and moist heat sterilization processes in accordance with ISO 11135, ISO 11137, and ISO 17665 respectively, covering all major sterilization modalities.
ISO 11607 — Sterile Packaging Validation
We validate sterile barrier systems per ISO 11607, conducting seal integrity, accelerated aging, and distribution simulation testing accepted by FDA, MDR, and all major international regulatory frameworks.
ISO 14971 — Risk Management
Arterex Medical supports full risk management file development per ISO 14971:2019, including hazard analysis, risk evaluation, and residual risk documentation aligned with FDA, MDR, and PMDA requirements.
ASTM F2097 / F88 / F1608 — Packaging Performance Testing
Our packaging lab conducts testing to ASTM F2097, F88, and F1608 standards, covering flexible packaging design, seal strength, and microbial barrier performance for sterile device submissions.
FDA 21 CFR Part 820 — Quality System Regulation
Arterex Medical operates in full alignment with FDA 21 CFR Part 820, ensuring every test record, report, and corrective action meets FDA’s design control and quality system requirements.
EU MDR 2017/745 — European Regulatory Alignment
Our testing and documentation fully align with EU MDR 2017/745, supporting Class I through Class III device submissions with technical documentation structured to meet MDR Annex II and III requirements.