Medical Device Design, Testing & Regulatory Certification
NexorTest delivers end-to-end medical device services — from engineering your product and testing it in our ISO/IEC 17025 accredited laboratories, to certifying it across 30+ global regulatory markets. One partner. Complete lifecycle.
Concept to Clearance — One Partner
Most medical device companies lose 6–18 months to handoffs between design firms, test labs, and regulatory consultants. NexorTest eliminates this friction by delivering all three capabilities under one roof, with shared knowledge and integrated project management.
01. Design & Engineering
Hardware design, embedded software, PCB, mechanical engineering, and industrial design — built for regulatory compliance from day one. Your idea, engineered to market specifications and global safety standards.
02. Testing & Validation
ISO/IEC 17025 accredited labs across India, Europe, UK, and UAE. EMC, electrical safety, biocompatibility, environmental, software validation, and cybersecurity testing — generating reports accepted by FDA, CE, CDSCO, and global regulators.
03. Global Regulatory Certification
Regulatory consulting and submission management across 30+ markets. FDA 510(k), CE/MDR, EU IVDR, CDSCO India, UKCA, TGA, SFDA, and more. Multi-market strategies designed for simultaneous launches, not sequential ones.
01
Product Design & Engineering
From napkin sketch to verified prototype — hardware, software, PCB, and mechanical engineering designed for regulatory compliance, manufacturing readiness, and global market access.
End-to-End Medical Device Engineering
Our multidisciplinary engineering teams bring deep medical device domain expertise, designing products that pass regulatory requirements on the first submission — not after costly redesigns.
Hardware & Electronics Design
Analog, digital, and mixed-signal circuit design. Power supply design (IEC 60601 compliant). RF/wireless subsystems (Bluetooth, Wi-Fi, Zigbee). Signal processing for sensors, imaging, and diagnostics. Applied part design (BF/CF rated)
Embedded Software & Firmware
IEC 62304 compliant software lifecycle. RTOS, bare-metal firmware, and embedded Linux. ARM Cortex, FPGA, and DSP development. Device drivers, protocol stacks (USB, Ethernet, BLE). AI/ML on-device inference for SaMD applications.
PCB Design & Layout
Multi-layer PCB design (up to 16+ layers). Signal integrity (SI) and power integrity (PI) analysis. EMC-aware layout for IEC 60601-1-2 compliance. Thermal management design. DFM/DFT (Design for Manufacture/Test) optimization.
Mechanical & Industrial Design
3D CAD design for medical device enclosures. IP-rated housing design (IP54–IP68). Injection moulding tooling and DFM. Wearable and handheld ergonomic design. Human factors engineering (HFE) and IEC 62366 usability compliance.
Design for Regulatory Compliance
Regulatory risk-by-design approach embeds FDA, EU MDR, and CDSCO requirements at the architecture stage. Design FMEA, hazard analysis (ISO 14971), creepage/clearance sizing for IEC 60601, biocompatibility material selection, and IEC 62304 software architecture.
Prototype Build & Pilot Production
Engineering prototypes, DVT (Design Validation Testing) builds, and pilot production units. EMS partner network in India and Europe. Test jig design and automated test equipment (ATE) development. Transfer to volume manufacturing with quality plan.
02
Medical Device Testing Services
ISO/IEC 17025 accredited laboratories generating test reports accepted by FDA, EU Notified Bodies, CDSCO, TGA, SFDA, and 30+ global regulators — covering every testing category from EMC to cybersecurity.
Accredited Medical Device Testing Laboratory
Comprehensive testing across all domains required for global regulatory submission — under one roof, with shared expertise and integrated test planning to minimize duplication and cost.
Full IEC 60601-1-2 EMC testing: radiated/conducted emissions, ESD, radiated immunity, burst, surge, conducted immunity, magnetic fields, voltage dips. FCC Part 15/18 for US market. CISPR 11 for EU.
- IEC 60601-1-2
- CISPR 11
- FCC Part 15
- IEC 61000-4 Series
Electrical Safety
IEC 60601-1 3rd edition complete testing: leakage current (earth, enclosure, patient, auxiliary), dielectric strength, PE resistance, applied part classification (B/BF/CF), fault conditions, creepage/clearance.
- IEC 60601-1
- IEC 60601-1-2
- IEC 62368-1
- IEC 60601-1-6
Biocompatibility (ISO 10993)
Risk-based biological evaluation per ISO 10993-1:2018. Cytotoxicity, sensitization, irritation, systemic toxicity, genotoxicity, implantation, hemocompatibility testing. Biological Evaluation Plan & Report for FDA/EU MDR.
- ISO 10993-1
- ISO 10993-5
- ISO 10993-10
- ISO 10993-4
Temperature cycling, humidity, vibration, shock, salt spray, altitude, IP ingress protection. Packaging validation (ASTM D4169, ISTA 2A/3A). Accelerated aging for sterile device shelf-life claims per ISO 11607.
- IEC 60068-2
- IEC 60529
- ASTM D4169
- ISO 11607
Software Validation (IEC 62304)
Software lifecycle verification & validation, IEC 62304 safety class determination, unit/integration/system testing, usability testing (IEC 62366-1), and AI/ML SaMD algorithm validation for FDA and EU MDR submissions.
- IEC 62304
- IEC 62366-1
- ISO 14971
- FDA SaMD
Vulnerability assessment, penetration testing, threat modeling (AAMI TIR57), SBOM generation (CycloneDX/SPDX), and FDA 2023 cybersecurity documentation. IEC 81001-5-1 compliance assessment for EU MDR.
- IEC 81001-5-1
- AAMI TIR57
- FDA 2023
- SBOM
03
Global Regulatory Certification
Regulatory consulting and submission management across 30+ global markets. Multi-market strategies, single dossier approach where possible, and full lifecycle compliance support from first submission to post-market surveillance.
Regulatory Certification Across 30+ Markets
From the world's largest medical device markets (FDA, CE, CDSCO) to fast-growing emerging markets in GCC, ASEAN, and Africa — NexorTest navigates every regulatory pathway.
🌐 Tier 1 — Major Global Markets
📈 Tier 2 — High-Growth Markets
🚀 Tier 3 — Emerging & ASEAN Markets
⭐ Special Programs
MDSAP — Multi-Country Audit
Medical Device Single Audit Program covering US FDA, Health Canada, Brazil ANVISA, Japan MHLW, and Australia TGA — one audit, five market access certificates.
SaMD & AI/ML Devices
Software as a Medical Device regulatory consulting across FDA, EU MDR, and CDSCO. AI/ML algorithm validation, predetermined change control plans (PCCP), and digital health regulatory strategy.
ISO 13485 QMS Consulting
Quality Management System establishment, gap assessment, and certification consulting aligned with ISO 13485:2016 requirements for FDA QMSR, EU MDR, CDSCO, and all global regulatory submissions.
How NexorTest Delivers Concept to Clearance
Our single-window process integrates design, testing, and certification into a seamless project — with shared documentation, parallel workstreams, and one project manager throughout.
Discovery &
Strategy
Market selection, regulatory pathway analysis, device classification, and project roadmap across Design, Test, and Cert.Product vision analysis, technical specs, target markets, regulatory mapping
Design &
Engineering
Regulatory-by-design product development with embedded compliance requirements — hardware, software, and mechanical.
V&V
Testing
Design verification testing and multi-market test campaigns in accredited labs — generating submission-ready evidence.
Regulatory
Submission
Technical dossier compilation and submission to FDA, CE Notified Body, CDSCO, and other target market regulators.
Clearance &
PMS
Regulatory clearance management, query responses, and ongoing post-market surveillance compliance support.
300+
30+
30%
Medical Device Services Questions Answered
Can NexorTest handle the entire journey from idea to FDA clearance?
Yes. NexorTest is specifically built as a single-window medical device partner. We start with your concept or existing design, apply regulatory-by-design engineering principles, build and test prototypes in our ISO/IEC 17025 accredited labs, and then prepare and submit the complete regulatory dossier to the FDA and other target markets. You deal with one project team, one contract, one invoice — eliminating the costly delays and communication gaps that occur when separate vendors hand off between design, testing, and regulatory phases.
What does regulatory-by-design mean and why does it matter?
Regulatory-by-design means embedding the requirements of target regulatory markets (FDA, EU MDR, CDSCO, etc.) into the engineering architecture from the very beginning of product development — not as an afterthought. For example, this means selecting materials based on ISO 10993 biocompatibility profiles, sizing creepage and clearance to IEC 60601-1 requirements, writing firmware to IEC 62304 safety class requirements, and designing RF subsystems to pass FCC Part 15 and IEC 60601-1-2 EMC from the outset. This approach eliminates expensive design-change cycles that typically occur when regulatory requirements are discovered late in development.
How does NexorTest help with multi-market launches (e.g., FDA + CE + CDSCO simultaneously)?
NexorTest’s integrated approach is specifically designed for multi-market launches. We create a single common technical documentation framework that satisfies the core requirements of all target markets, then add market-specific supplements (e.g., FDA 510(k) summary, EU MDR technical documentation per Annex II/III, CDSCO Form MD-14/15). Test campaigns are planned to generate data accepted by all regulators simultaneously — for example, IEC 60601-1-2 EMC test data satisfies both FDA and CE requirements. This approach typically reduces total multi-market launch cost by 40-50% compared to running separate market entries sequentially.
What industries does NexorTest serve beyond medical devices?
While our primary focus and deepest expertise is in medical devices and healthcare technology, NexorTest also serves adjacent industries including Defence & Aerospace (MIL-STD, DO-160, DEF STAN), Automotive & EV (IATF 16949, AEC-Q series, UNECE R10), Industrial & IoT equipment, Telecom infrastructure, and Consumer Electronics. Many of our clients are companies expanding from consumer electronics into healthcare, where our dual expertise in both domains is particularly valuable.
Ready to Launch Your Medical Device?
Whether you’re at concept stage, need testing for submission, or require regulatory certification — get a free consultation with NexorTest’s medical device experts today.