End-to-end support across the device lifecycle.

QMS & Standards

Quality Management Systems (QMS)

Development and implementation of Quality Management Systems in compliance with international standards, along with the structuring of technical documentation in accordance with global regulatory requirements:

• MDSAP — Medical Device Single Audit Program (Australia, Brazil, Canada, Japan, USA)
• ISO 13485:2016 — Medical devices QMS for regulatory purposes
• EU MDR / IVDR — including dossier preparation, CEP and CER for SaMD
• US FDA 21 CFR Part 820 / QMSR — Quality Management System Regulation
• ISO/IEC 27001 — Information Security Management System (ISMS)
• ISO/IEC 27701 — Privacy Information Management System (PIMS)
• ISO/IEC 42001 — Artificial Intelligence Management System (AIMS)
• ISO 9001 — General quality management
• Coaching and training to prepare for ISO 13485 certification, including support with management reviews and supplier qualifications
• Implementation of risk management processes in compliance with ISO 14971
• Facilitating data-driven continuous QMS improvements

SS 620:2016 — GDPMDS, Singapore

• Development and implementation of QMS in compliance with SS 620:2016 (2021) — Good Distribution Practice for Medical Devices (GDPMDS)
• Assisting medical device manufacturers, healthcare companies, and distributors in establishing commercial operations for the importation and sale of their products in Singapore

Regulatory Strategy

Comprehensive Regulatory Solutions: Strategy, Technical Documentation & Submissions

Regulatory Strategy Development — we design tailored regulatory strategies that align with your product goals and target markets, ensuring compliance and smooth navigation through complex requirements.

Technical Documentation (TD) Preparation — our team prepares comprehensive technical documentation that meets international standards, supporting successful evaluations and submissions.

Regulatory Submissions & Market Entry — we manage submissions for medical device registration with leading regulatory agencies and oversee the process across diverse markets, enabling timely market entry.

Key Regulatory Agencies — Direct Support

Through Partner Network

WHO Prequalification Programme (WHO PQP) — In Vitro Diagnostic Devices

The WHO Prequalification programme is a globally recognised quality assurance initiative ensuring diagnostic devices meet international standards. Achieving WHO Prequalification is often a critical milestone for manufacturers seeking access to global procurement agencies, NGOs, and public health programmes — especially in low and middle-income countries.

• Gap Assessment & Strategy — evaluating your device against WHO requirements and creating a tailored compliance roadmap
• Technical Documentation — structuring dossiers, performance data, and quality documentation in line with WHO PQP standards
• Clinical & Performance Evidence — guiding the design, execution, and reporting of studies to demonstrate safety, accuracy, and reliability
• QMS Alignment — ensuring your QMS meets WHO expectations, including ISO 13485 and relevant regulatory frameworks
• Stakeholder Engagement — supporting communication with WHO reviewers, procurement agencies, and national regulatory authorities
• Training & Capacity Building — equipping your teams with knowledge of WHO PQP processes and best practices

Authorized Registrant & Local Authorized Representative

• Holding and annual retention of licences as your authorised registrant and local representative

Post-Market Surveillance & Compliance

• Management of change notifications and amendments to product registrations
• Safety monitoring and reporting — complaint handling, adverse event reporting, and Field Safety Corrective Actions (FSCAs)

SaMD · AI · Privacy

Regulatory Affairs

• Guidance on information security and data protection compliance — GDPR, HIPAA, Singapore Cyber Essentials, and Cyber Trust Certification
• Risk assessment and mitigation strategies for digital health technologies to ensure regulatory compliance and operational security

Quality Assurance & Compliance

Implementation of management systems for:

• ISO/IEC 27001 — Information Security Management System (ISMS)
• ISO/IEC 27701 — Privacy Information Management System (PIMS)
• ISO/IEC 42001 — Artificial Intelligence Management System (AIMS)

Pre-Clinical

Pre-Clinical Activities

• Define pre-clinical test strategy and support in selection of appropriate animal model
• Protocol development and study design support
• Investigator’s Brochure (IB)
• Guidance on Good Laboratory Practice (GLP) expectations (21 CFR Part 58) and documentation readiness
• Development of sponsor oversight plans and study quality documentation

Clinical Affairs

Clinical Affairs

• Define clinical strategies and Clinical Development Plans (CDPs) for EU and US market access
• Write Clinical Evaluations compliant with EU, TGA, HSA, and CDSCO requirements
• Establish Post-Market Clinical Follow-up (PMCF) Plans and Reports
• Design clinical investigations following Good Clinical Practice (GCP) and ISO 14155
• Prepare Clinical Trial Applications (CTA) and oversight of studies in the EU (MDR, GCP)
• Prepare Investigational Device Exemption (IDE) submissions for the US per 21 CFR 812
• Manage interactions with Regulatory Authorities, Ethics Committees, and IRBs

Strategy & Entry

• Health Technology Assessment (HTA) — economic and clinical value evaluation for reimbursement and procurement
• Market Opportunity Assessment — competitive intelligence, market sizing, and pathway analysis
• Singapore Company Registration Services — comprehensive solutions for establishing your APAC Regional Headquarters via an ACRA-registered Filing Agent
• Distributor Search Service — identifying and evaluating distributors in Singapore, India, and Southeast Asia with proven expertise in medical devices and diagnostics

Writing & Illustration

• Medical writing for journals — peer-reviewed publications, white papers, and clinical narratives
• Scientific illustrations to communicate complex medical concepts — surgical anatomy, mechanisms of action, and device-tissue interactions

Quality Assurance

Training — Quality Assurance

• Management systems: ISO 9001, ISO 13485, EU MDR/IVDR, MDSAP
• Continuous improvement
• Internal & supplier audits
• Corrective Actions & Preventive Actions (CAPA)
• Statistical Process Control (SPC) & data analysis
• Computer System Validation
• QMS software validation per ISO/TR 80002-2
• 21 CFR Part 11 compliance
• GAMP / GxP system assessment and validation

Regulatory

Training — Regulatory Services

• Target Product Profile (TPP)
• Regulatory frameworks: EU MDR/IVDR (incl. UK and CH), US FD&C Act, India MDR 2017, ASEAN MDD, Australia TG(MD)R 2002
• Topic-specific: Design controls, ISO 14971, Usability (IEC 62366), Post-Market Surveillance, UDI, EUDAMED

SaMD & Digital Health

Training — SaMD / Digital Health

• Health Software: IEC 82304-1:2016, IEC 62304:2006, IEC 81001-5-1:2021 (Cybersecurity)
• AI/ML & Data security: EU AI Act, AI Lifecycle ISO/IEC 5338, EU/UK/CH GDPR, HIPAA, CPRA
• National programmes: SG Cyber Essentials & Cyber Trust, Germany DiGA, UK Cyber Essentials+, Spain ENS
• Management systems: ISO 27001 (Info Security), ISO 27701 (Privacy), ISO 42001 (AI)