Medical Devices
On-Site Support
Remote Support
Hybrid Support
Top Standards
Medical Devices
Your trusted partner for navigating the complex landscape of medical device regulations in Singapore and worldwide
Training & Certification Programs
Equip your team with industry-leading knowledge through our specialized training programs designed specifically for medical device professionals. Our comprehensive curriculum covers critical areas including ISO 13485, GDPMD, and GMD/IVD regulations, ensuring your organization stays ahead of compliance requirements.
The Certified Medical Device Compliance Professional (CMDCP) program provides participants with recognized credentials that validate expertise across the entire medical device lifecycle4from
initial design through clinical trials to quality management and regulatory submissions.
We understand that different organizations have unique learning needs, which is why we offer flexible delivery options:
- Instructor-led onsite training at your facility
- Interactive virtual classrooms with live Q&A sessions
- Self-paced online modules for convenience
Multilanguage support for global teams
Our modular approach allows participants to select core requirements plus elective specializations that align with their specific career paths and organizational needs. Whether you’re looking to train a single employee or implement company-wide compliance education, our programs scale to meet your objectives.
Related compliances
Consulting Services for Medical Devices
Strategic Regulatory Pathways
We develop customized regulatory strategies that optimize your path to market. Our experts conduct thorough compliance gap analyses to identify potential issues before they become costly problems, helping you navigate Singapore HSA requirements and international regulations efficiently
Full Product Lifecycle Support
From initial concept through design, manufacturing, and post-market surveillance, our consultants provide expert guidance at every stage. We help integrate regulatory considerations into your development process, reducing delays and ensuring smoother approvals
International Market Access
Our specialized knowledge of Singapore's Health Sciences Authority requirements combined with expertise in global regulations ensures your products meet standards for multiple target markets simultaneously, optimizing your regulatory investment.
Our consulting team includes former regulatory officials, quality system experts, and medical device specialists with decades of combined experience. We pride ourselves on providing practical, implementation-focused advice rather than theoretical guidance, helping you achieve tangible results and real-world compliance.
Clinical Trial Support & Compliance
Successful clinical investigations are crucial for demonstrating medical device safety and performance. Our specialized clinical trial support services guide manufacturers through the entire investigation process, from initial planning through final reporting and regulatory submission.
1. Clinical Investigation Planning
We develop comprehensive clinical investigation plans that align with regulatory expectations and scientific best practices. Our team helps determine appropriate study designs, endpoints, and sample sizes to generate compelling evidence for your device's safety and effectiveness.
2. Ethical & Regulatory Approvals
Navigating ethics committee reviews and regulatory submissions requires specialized knowledge. We prepare documentation for Institutional Review Boards (IRBs), Singapore HSA applications, and other regulatory bodies, ensuring all ethical and legal requirements are satisfied before your study begins.
3. Data Collection & Management
Our clinical specialists help implement robust data collection protocols and management systems that ensure data integrity throughout your investigation. We assist with case report form design, monitoring procedures, and statistical analysis planning to generate reliable, defensible results.
4. Regional Regulatory Expertise
Clinical investigation requirements vary significantly across markets. Our team's specialized knowledge of Singapore HSA and broader ASEAN regional requirements helps ensure your studies satisfy local regulations while also supporting global marketing applications.
Risk Management & Compatibility Testing
Comprehensive Risk Management Solutions:
Effective risk management is fundamental to medical device safety and regulatory compliance. Our specialized services help manufacturers implement robust risk management processes aligned with ISO 14971 standards throughout the product lifecycle. Our approach integrates risk management with your broader quality
system, ensuring hazards are systematically identified, risks are properly evaluated, and appropriate controls are implemented and verified. Our services include:
- Development of risk management plans and files
- Facilitation of risk analysis workshops
- Implementation of risk evaluation methodologies
- Integration of risk controls into design outputs
- Preparation of risk-benefit analyses
- Development of post-market surveillance plans
Compatibility Testing & Verification
We provide comprehensive compatibility assessment services to verify your medical device’s safety and performance in its intended use environment. Our testing protocols address:
- Biological compatibility (biocompatibility) according to ISO 10993
- Chemical compatibility with medications, cleaning agents, and
biological fluids - Functional compatibility with accessories and connected systems
- Environmental compatibility across storage and usage conditions
Our documentation seamlessly integrates with your technical files, providing clear evidence of safety and performance for regulatory submissions worldwide.
Labelling Design & Multilingual Documentation
Clear, compliant labeling and documentation are essential for both regulatory approval and safe device use. Our specialized labeling and documentation services ensure your materials satisfy complex global requirements while effectively communicating critical information to users in multiple languages.
Regulatory-Compliant Label Design
Our experts create medical device labels that satisfy Singapore HSA requirements and international standards. We ensure all required elements4including unique device identifiers, symbols, warnings, and instructions4are properly displayed according to the latest regulations for each target market.
Multilanguage Support
We provide comprehensive translation and localization services for all user-facing and regulatory documentation. Our specialized medical translators ensure technical accuracy while adapting content appropriately for cultural and regional differences across markets.
Documentation Systems
Beyond creating individual documents, we help establish sustainable documentation systems that maintain consistency across product lines and facilitate efficient updates when regulations change. Our structured approach ensures your labeling remains compliant throughout the product lifecycle
Our labeling expertise extends to electronic instructions for use (eIFU), implant cards, and special documentation requirements for different device classifications. We ensure your documentation strategy satisfies GMD and IVD regulations while supporting effective post-market surveillance and vigilance reporting.
Authorized Representative & Product Registration
Trusted Local Representation:
For foreign manufacturers seeking to enter the Singapore market, we provide comprehensive authorized representative services that satisfy local regulatory requirements. As your official local representative, we:
- Maintain copies of your technical documentation for regulatory purposes
- Serve as the primary contact point for Singapore HSA communications
- Assist with adverse event reporting and field safety notifications
- Monitor regulatory changes that may affect your products
- Facilitate communication between manufacturers and authorities
Complete Registration Management:
Our product registration services handle every aspect of the submission process with the Singapore Health Sciences Authority. From initial classification determination through dossier preparation and submission, we manage the entire process to ensure efficient approval.
We leverage our established relationships with regulatory authorities and in-depth understanding of local requirements to minimize delays and resolve questions efficiently, helping you achieve market access as quickly as possible.
Compatibility Testing & Verification
We provide comprehensive compatibility assessment services to verify your medical device’s safety and performance in its intended use environment. Our testing protocols address:
- Biological compatibility (biocompatibility) according to ISO 10993
- Chemical compatibility with medications, cleaning agents, and
biological fluids - Functional compatibility with accessories and connected systems
- Environmental compatibility across storage and usage conditions
Our documentation seamlessly integrates with your technical files, providing clear evidence of safety and performance for regulatory submissions worldwide.
Why Choose Us: Value & Support
15 +Years of Expertise
Over fifteen years of specialized experience in medical device compliance, quality systems, and regulatory affairs across global markets
500+ Successful Projects
We've guided hundreds of medical device manufacturers through successful product approvals and quality system certifications worldwide.
100% Client Satisfaction
Our commitment to excellence has earned us perfect satisfaction ratings from clients ranging from startups to multinational corporations.
Our cross-border expertise spans the United States, European Union, ASEAN countries, and Singapore, allowing us to provide truly integrated global solutions. We maintain specialists in each major regulatory system to ensure accurate, up-to-date guidance as requirements evolve. We pride ourselves on offering scalable solutions that work for organizations of all sizes. Whether you’re a startup bringing your first device to market or a multinational corporation managing a diverse product portfolio, we tailor our services to match your specific needs and resources. When you partner with us, you gain more than just a service provider4you get a dedicated support team committed to your success. Our clients enjoy exclusive access to our regulatory resource library, regular compliance updates, and priority response when urgent issues arise.
