Asia's Leading Medical Device Consultancy

From Idea to
Approved
Medical Device

QUASYS guides medical startups and enterprises from concept through design control, clinical validation, and regulatory approval — in every major market worldwide.

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19+
Years Experience
50+
Countries Served
23+
Medical Domains
100%
Client Satisfaction
🏆
ISO 13485 Expert
Quality Management Systems

Your Journey to Market

01
Concept & FeasibilityUser needs · Market strategy · Risk classification
02
Design Control PlanInputs · Outputs · Traceability matrix
03
SW DevelopmentIEC 62304 · SaMD · AI/ML · Embedded
04
Verification & ValidationClinical evidence · HFE · Cybersecurity
05
Regulatory ApprovalFDA · CE · MDR · TGA · 50+ markets
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Global Registrations
FDA · CE · TGA · PMDA · ANVISA
◆ Design Control ◆ IEC 62304 Software ◆ AI / ML SaMD ◆ Surgical Robotics ◆ FDA 510(k) ◆ CE Marking ◆ Clinical Evaluation ◆ Cybersecurity ◆ HIPAA Compliance ◆ ISO 13485 ◆ Risk Management ◆ Usability Engineering ◆ Design Control ◆ IEC 62304 Software ◆ AI / ML SaMD ◆ Surgical Robotics ◆ FDA 510(k) ◆ CE Marking ◆ Clinical Evaluation ◆ Cybersecurity ◆ HIPAA Compliance ◆ ISO 13485 ◆ Risk Management ◆ Usability Engineering
Medical device laboratory team
19+
Years of Medical Device Consulting Excellence
About QUASYS

Asia's Most Trusted Medical Device Partner

QUASYS is the most valuable and experienced Medical Device Consulting Company in Asia. For over 19 years, we have partnered with medical device companies — from emerging startups to the world's largest organizations — across the USA, Europe, and Asia Pacific.

We aren't just lifelong consultants or template developers. With decades of corporate experience, we navigate the complexities of medical device development to deliver meaningful innovation. Our team has hands-on expertise in technical, management, marketing, and regulatory requirements.

"We accelerate speed to market, REDUCE risks and ENHANCE COMMERCIALIZATION success."

We are one of the top consultants in the world with hands-on experience dealing with Medical Devices with Software — both Software as Medical Device and Medical Devices having Software as part of them.

Medical Device Product Development
Training & Academy
Quality Management Certifications
Regulatory Approvals
Clinical Validation
Marketing & Business Strategy
Our Services

End-to-End Medical Device Consulting

From the first whiteboard sketch to world-market commercialization — QUASYS covers every discipline your device needs.

🎯

Design Control

Complete design control framework per FDA 21 CFR Part 820, ISO 13485, and EU MDR 2017/745. Design History File management from day one.

DHFDesign InputsRTMV&V
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Software Development

IEC 62304-compliant software lifecycle management. Full-stack medical device software, embedded firmware, and SaMD development.

IEC 62304SaMDEmbeddedAI/ML
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Regulatory Approvals

Market access strategy and registration across 50+ countries. FDA 510(k), CE Marking, TGA, PMDA, ANVISA, and all major global markets.

FDACE MDRTGAPMDA
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Clinical Validation

Clinical Evaluation Reports (CER), PMCF planning, IDE submissions, and complete clinical evidence generation for regulatory submissions.

CERPMCFIDEMDR Annex XIV
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Cybersecurity & Privacy

FDA pre/post-market cybersecurity, HIPAA compliance, GDPR Privacy by Design, IEC 81001-5-1, and threat modeling for connected devices.

HIPAAGDPRIEC 81001FDA Cyber
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Usability Engineering

Human Factors Engineering per IEC 62366-1. Formative and summative usability evaluations, use-related risk analysis, and HFE documentation.

IEC 62366HFESummativeUse-Error
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Risk Management

ISO 14971:2019 risk management from hazard identification through benefit-risk justification. FMEA, FTA, and post-market vigilance.

ISO 14971FMEAFTAPSUR
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Quality Systems

ISO 13485:2016 QMS design and implementation. FDA QSR, MDSAP audit readiness, GMP assessments, CAPA systems, and document control.

ISO 13485QSRMDSAPCAPA
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Post-Market & Surveillance

Post-market surveillance systems, vigilance reporting, PSUR preparation, post-market clinical follow-up (PMCF), and complaint handling.

PMSVigilancePMCFMDR Art. 85
Design Control

The Foundation of Every Successful Device

Design control decisions made at the beginning of R&D profoundly impact your market outcome. We build the right framework before development starts.

01
Design & Development Planning
Scope, milestones, team roles, risk classification, applicable standards
02
Design Input
User needs → functional, performance & safety requirements
03
Design Output
Drawings, specs, software architecture, test plans, labeling
04
Design Review
Independent review at defined milestones — documented and traceable
05
Design Verification
Confirming the device meets design outputs through objective testing
06
Design Validation
Confirming the device meets user needs and intended use
07
Design Transfer
Manufacturing-ready specifications, procedures, and production records

QUASYS Delivers

Design History File (DHF) management
Design Input / Output documentation
Traceability matrix (RTM) development
Design review facilitation & minutes
Verification & Validation protocols
Clinical Evaluation Reports (CER)
Technical File / Design Dossier
Post-market surveillance plan

Standards Covered

FDA 21 CFR 820 ISO 13485 EU MDR 2017/745 IVDR 2017/746 ISO 14971 IEC 62304 IEC 62366 IEC 60601-1 ISO 10993 IEC 81001-5-1
Technology Capabilities

Cutting-Edge Tech for Modern Medical Devices

From embedded firmware to AI-powered diagnostics — QUASYS has the deep technical expertise your device demands.

Medical device software development

Software as a Medical Device (SaMD)

QUASYS is among the world's pioneers in SaMD, with experts working in this domain since 2000. We have cleared devices across US, Europe, Asia, and Australia regulations many times.

IEC 62304 software lifecycle compliance — all classes
SaMD classification and regulatory pathway determination
Embedded software in medical hardware devices
Integrated pharmaceutical management systems
Clinical trial management solutions (CTMS)
Laboratory Information Systems (LIS)
Mobile medical applications — iOS and Android
AI medical imaging

AI / Machine Learning in Medical Devices

We have successfully validated and cleared AI-powered medical devices across ophthalmology, radiology, pathology, and disease management — navigating the FDA's AI/ML SaMD action plan and EU MDR requirements.

AI diagnostic imaging: X-Ray, CT, MRI, Fundus, Ultrasound, Mammogram
Good Machine Learning Practice (GMLP) compliance
FDA SaMD AI/ML action plan readiness & PMA strategy
AI model validation — bias, transparency, performance
Ophthalmology AI: Diabetic Retinopathy, Glaucoma, AMD
Radiology AI: Lesion detection and quantification
AI-driven disease management and analytics platforms
Surgical robotics

Surgical Robotics & Automation

Deep expertise in robotic surgical systems — from software architecture and safety validation to regulatory submission. We have worked on endoscopy, renal, prostate, ENT, and automated positioning systems.

Robotic surgical systems: Endoscopy, Renal, Prostate, ENT
Automated surgical instrument positioning systems
Robotic device software control & safety architecture
Image-guided robotic surgery solutions
IEC 60601-1 compliance for robotic systems
Functional safety analysis (IEC 62061 / ISO 13849)
Real-time control software validation
Medical device product design

Product Design & Engineering

Using advanced technologies and deep understanding of clinical users, our development team turns visions and goals into beautifully designed, clinically validated, manufacturable products.

Front-end & UX-led medical device product design
Mechatronics and hardware architecture design
Prototyping & proof-of-concept builds
Industrial design and human factors integration
Productization and manufacturing readiness
Database architecture and clinical data systems
Full software development — IEC 62304 compliant
Cybersecurity & Privacy

Security Built In, Not Bolted On

Medical device cybersecurity and patient data privacy are regulatory requirements — not optional. QUASYS integrates security from the first design decision.

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Medical Device Cybersecurity

FDA pre-market and post-market cybersecurity guidance compliance, IEC 81001-5-1 for health software, and full threat modeling.

STRIDE threat modeling & attack surface analysis
IEC 81001-5-1 cybersecurity for health software
FDA pre-market cybersecurity submissions
Vulnerability management & SBOM
Secure development lifecycle (SDL)
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HIPAA & Data Privacy

Comprehensive HIPAA compliance consulting and GDPR Privacy by Design implementation for medical devices handling patient data.

HIPAA Security Rule & Privacy Rule compliance
GDPR Article 25 — Privacy by Design
PHI/PII data flow mapping & access control
Business Associate Agreement (BAA) guidance
Data breach response planning
☁️

Connected Device & Cloud Security

IoT medical device communication security, cloud-hosted SaMD architecture review, and electronic records compliance.

IoT device communication security (TLS/mTLS)
Cloud-hosted SaMD security architecture
API security & authentication design
21 CFR Part 11 & EU Annex 11 compliance
Penetration testing coordination
IEC 81001-5-1 HIPAA Security Rule GDPR Article 25 FDA Cyber Guidance 2023 NIST Cybersecurity Framework 21 CFR Part 11 EU Annex 11 ISO 27001
Global Regulatory

Market Access in 50+ Countries

QUASYS builds a global regulatory strategy early — mapping timelines, dossier requirements, and parallel submission opportunities to minimize your time to market.

🇺🇸
United States (FDA)
CDRH · CDER · 21 CFR
510(k) Substantial Equivalence submissions
De Novo Pathway for novel devices
PMA (Class III devices)
IDE submissions for US Clinical Trials
FDA QSR (21 CFR Part 820) compliance
FDA pre-submission (Q-Sub) meetings
🇪🇺
Europe (EU MDR/IVDR)
MDR 2017/745 · IVDR 2017/746
CE Marking — MDR 2017/745 compliance
IVDR 2017/746 in vitro diagnostic devices
Notified Body Technical File review
Clinical Evaluation per Annex XIV
Declaration of Conformity preparation
EUDAMED registration support
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Asia-Pacific & Global
TGA · PMDA · CFDA · CDSCO
Australia TGA Registration
Japan PMDA Device Approval
China NMPA (CFDA) Registration
India CDSCO Medical Device Registration
Singapore HSA, Malaysia MDA
MDSAP audit readiness
Also covering
🇧🇷 Brazil ANVISA 🇨🇦 Canada Health Canada 🇰🇷 Korea MFDS 🇲🇽 Mexico COFEPRIS 🇷🇺 Russia Roszdravnadzor 🇸🇬 Singapore HSA 🇮🇩 Indonesia BPOM 🇹🇭 Thailand FDA 🇵🇭 Philippines FDA 🇨🇭 Switzerland Swissmedic 🇹🇼 Taiwan TFDA/TCP 🇿🇦 South Africa SAHPRA
Clinical & Usability

Evidence That Earns Regulatory Trust

User acceptability and clinical validation are non-negotiable for approval. QUASYS builds the evidence systematically.

🔬 Clinical Evaluation (CER/CEP)

Clinical Evaluation Reports per MDR Annex XIV and MEDDEV 2.7.1 Rev.4. Equivalent device analysis, systematic literature review, and PMCF planning.

💊 Medical Device Software Validation

CSV protocols per 21 CFR Part 11 and EU Annex 11. Test case creation, execution, and validation summary reports. IQ/OQ/PQ documentation.

📊 Post-Market Clinical Follow-Up

PMCF plan design, periodic safety update reports (PSUR), post-market surveillance reports, and vigilance system implementation.

ISO 14155 Clinical Investigations Design and oversight of clinical investigations for medical devices, including IDE submissions, protocol development, clinical site coordination, and data analysis for regulatory submissions.

Usability Engineering

IEC 62366-1 / HFE — Making your device safe through user understanding

1
Intended Use & User Profile
Define intended users, clinical environments, and critical tasks that must be performed safely
2
Use-Related Risk Analysis
Identify hazardous situations arising from use errors, misuse, and foreseeable misuse scenarios
3
Formative Evaluations
Iterative prototype usability testing with target users — uncovering design issues early
4
User Interface Specification
Finalizing UI requirements and design informed by user research and risk analysis
5
Summative Evaluation
Final simulated-use testing with representative users — objective safety evidence for regulators
6
Usability File & Report
Regulator-ready HFE documentation for 510(k), CE marking, MDR Technical File
Risk & Quality

Quality and Safety at Every Stage

Embedded into every phase of development — not added at the end. QUASYS builds robust quality and risk management systems that satisfy every major regulator.

⚠️

Risk Management

ISO 14971:2019
Hazard identification and P(H) estimation
Risk acceptability criteria and risk matrix
FMEA (Failure Mode & Effects Analysis)
FTA (Fault Tree Analysis)
Risk control measures and residual risk
Benefit-risk justification documentation
Post-market risk monitoring integration
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Quality Management Systems

ISO 13485:2016 · FDA QSR
ISO 13485:2016 QMS design and implementation
FDA QSR (21 CFR Part 820) compliance
GMP assessments — Japan PAL, Brazil ANVISA
Medical Device Single Audit Program (MDSAP)
Document control and training systems
CAPA system design and investigation support
Complaint handling and feedback systems
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Cybersecurity Risk Management

IEC 81001-5-1 · FDA 2023 Guidance
Cybersecurity risk assessment integration with ISO 14971
Threat modeling: STRIDE, PASTA methodologies
Software Bill of Materials (SBOM) management
Post-market cybersecurity patch management
Coordinated vulnerability disclosure process
FDA cybersecurity submission documentation
🧠

Good Machine Learning Practices

FDA GMLP · EU AI Act
GMLP compliance for AI/ML in clinical use
AI model transparency and explainability
Bias detection and mitigation strategies
Continuous learning device management
AI validation — performance metrics & ground truth
EU AI Act high-risk AI system compliance
Track Record

Proven Across 23+ Medical Domains

From diagnostic imaging to surgical robotics — our clients span the full breadth of the medical device industry.

19+
Years Experience
50+
Countries
23+
Medical Domains
100%
Client Satisfaction
Diagnostic Imaging (MRI, CT, Ultrasound)
AI/ML Diagnostic Software
Surgical Robotics & Automation
Image-Guided Surgery
In Vitro Diagnostics (IVD)
Real-time PCR Systems
Automated Tissue Diagnostics
Digital Pathology
Ophthalmology Devices & AI
Radiology AI Solutions
Wearable & Handheld Devices
Mobile Medical Applications
Rehabilitation Devices
Hearing Aids & Eyewear
Dialysis Machines
Electronic Stethoscopes & ECG
Dental Implants
Wound Care Solutions
Hospital Information Systems
Clinical Trial Systems
Personal Protective Equipment
Collagen & Biomaterials
Tele-Imaging (Radiology & Ophthalmology)
Electrical Muscle Stimulators
Work With Us

Flexible Engagement Models

Choose the partnership structure that fits your stage, budget, and team. QUASYS adapts to you — not the other way around.

🤝

Retainer Consultancy

Most Popular

Monthly retainer for ongoing regulatory and quality guidance. Best for startups needing continuous expert support without full-time hires.

Dedicated QUASYS consultant
Ongoing regulatory guidance
Monthly reporting & reviews
Flexible scope adjustment
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Project-Based

Defined scope, timeline and deliverables. Ideal for specific milestones: 510(k) submissions, V&V protocols, or clinical evaluations.

Fixed deliverables & timeline
Clear scope & milestones
Expert team per domain
Full documentation ownership
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Outsourced Reg Team

QUASYS acts as your regulatory and quality department. Full accountability, audit readiness, and continuous compliance monitoring.

Full department replacement
Audit-ready at all times
Continuous compliance monitoring
Global regulatory coverage
⚙️

Outsourced Dev Team

Full Service

End-to-end design and software development. Your dedicated QUASYS team handles all technical deliverables and design control outputs.

Full design & dev capability
IEC 62304 compliant process
Design control ownership
Technical file ready
QUASYS Academy

Public & In-House Training Programmes

QUASYS Academy provides comprehensive training covering all critical topics in the medical device industry — from regulatory fundamentals to advanced software validation.

Implementing ISO 13485 Quality Management Systems
ISO 13485 Internal Auditor Training
FDA QSR (21 CFR Part 820) for Medical Device Companies
EU MDR 2017/745 & IVDR Compliance and CE Marking
Risk Management — Complying with ISO 14971:2019
Medical Device Software Design (IEC 62304)
Design Control and Product Validation Workshop
Medical Device Cybersecurity (IEC 81001-5-1)
Usability Engineering per IEC 62366-1
Process Validation Requirements & Best Practices
Request Training ›
Medical device training

Ready to Bring Your Device to Market?

Talk to a QUASYS expert today. We'll map out your fastest, most defensible path from concept to approval.

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Let's Build Something That Saves Lives

Whether you're a first-time founder with a device idea or an established manufacturer entering a new market — QUASYS has the expertise to guide you.

🌐
Website
www.quasys.net
📧
Email
john@quasys.net
📍
Headquarters
138 Robinson Road #02-26 Singapore 068906
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Response Time
Within 24 hours
Why Clients Choose QUASYS
✓ 19+ years hands-on experience — not just templates
✓ Pioneer in AI/ML SaMD cleared globally
✓ One-stop solution — technical + regulatory + clinical
✓ Global reach: startups to Fortune 500

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