We support medtech industry with our expertise

Design, development, implementation and support for continuous maintenance of Quality Management Systems (QMS) in compliance with international standards.

• ISO 9001/ ISO 13485, EU MDR/ IVDR, 21 CFR 820, MDSAP, ICH Q10 etc.,

Coaching/training in preparation for ISO 13485 certification, including support with management reviews, and supplier qualifications.

Implement and maintain Risk Management processes in compliance with ISO 14971.

Conducting internal and supplier audits to ensure regulatory compliance.

Provide hands-on support during audits and inspections and assist in remediating non-conformities.

Establish and maintain Post-Market Surveillance processes, including complaint handling, adverse event reporting and FSCAs.

Facilitate data-driven continuous QMS improvements.

Training programs on Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), Good Documentation Practices (GDP) and Good Clinical Practices (GCP).

Support with Product qualification and classification.

Regulatory strategy development for product approvals in the EU, U.S., and other global markets (Australia, Canada, GCC, India, ASEAN territory etc.,).

Preparation of technical documentation / regulatory dossiers for obtaining marketing authorization (pre-market and post market).

Support FDA interactions, including Q-submissions, 510(k), De Novo, PMA, BDD, STeP, and 513(g) applications.

Support with risk management activities in line with ISO 14971 and Human factors / Usability engineering activities in accordance with IEC 62366-1, FDA Human Factors guidance, IEC 60601-1-6 usability for medical electrical equipment.

Support V&V activities, including product specific verification activities, and usability validation per IEC 62366.

Liaison with notified bodies and regulatory agencies.

Product registration with national regulatory authorities.

Post-market surveillance and regulatory compliance maintenance.

WHO Pre-Qualification for IVDs

Deliver Regulatory Affairs training tailored to your needs

Establish and periodic updates of Clinical Evaluation Plans (CEP) and Reports (CER) as per applicable legislative requirements following MEDDEV 2.7/1 Revision 4, MDR and with all relevant MDCG guidance documents.

Establish post-market surveillance plans (PMS Plans), periodic safety update reports (PSURs).

Support with Post market clinical follow-up (PMCF) and real-world evidence (RWE) studies.

Establish and periodic updates to Summary of safety and clinical performance (SSCP)

Optimization of Quality Management Systems (QMS) for Agile Development

• Tailored adaptation of ISO 13485-compliant QMS frameworks to align with modern agile and DevOps methodologies, enabling rapid iteration without compromising compliance or traceability.

Software Development Lifecycle (SDLC) Compliance per IEC 62304

• End-to-end support for implementing and documenting IEC 62304-compliant SDLC processes, including software classification, architecture definition, verification & validation planning, and maintenance controls.

Comprehensive Software Risk Management and Cybersecurity Assessments

• Execution of software risk assessments in accordance with ISO 14971 and IEC 81001-5-1, including cybersecurity risk evaluation per AAMI TIR57 and FDA premarket cybersecurity guidance.

Implementation and Maintenance of Information Security Management Systems (ISMS)

• Design, deployment, and continuous improvement of ISMS frameworks compliant with ISO/IEC 27001, ensuring confidentiality, integrity, and availability of sensitive health data and AI model assets.

Regulatory Support for Data Protection and Privacy Compliance (GDPR, HIPAA, and Global Equivalents)

• Guidance on integrating privacy-by-design principles into software architecture, ensuring alignment with EU GDPR, U.S. HIPAA, and other international data protection requirements relevant to SaMD/AIaMD.

Evaluation and Strategic Support for DiGA (Digital Health Applications) Listing

• End-to-end support for market access in Germany via the DiGA Fast Track, including evidence generation, BfArM dossier preparation, and navigation of data protection, interoperability, and reimbursement criteria

AI/ML Lifecycle Management in Alignment with FDA GMLP and EU AI Act

• Structured governance of the AI/ML model lifecycle—from data acquisition and model development to deployment and post-market monitoring—ensuring compliance with FDA's Good Machine Learning Practices (GMLP) and upcoming EU AI Act obligations, including conformity assessments and risk-based classification.

AI-Specific Risk Management Frameworks

• Implementation of robust AI risk management processes integrating ISO 14971, IEC 81001-5-1, and AI-specific risk factors such as data drift, model degradation, robustness, and misuse. Includes assessment of algorithmic risk, performance consistency, and safety impacts across diverse patient populations.

AI Transparency, Bias Mitigation, and Explainability Strategies

• Development of documentation and evidence to support transparency and trustworthiness of AI systems, including:

  • Bias detection and mitigation plans

  • Model explainability techniques suited to clinical context

  • Alignment with ethical AI principles and regulatory expectations for transparency and human oversight (e.g., EU AI Act Articles 13 & 14, FDA transparency initiatives)

Medical device manufacturers located outside the European Union are legally required to appoint a qualified EU Authorized Representative (EC-Rep) to act on their behalf in fulfilling the obligations outlined in the EU MDR and IVDR.

Under EU Artificial Intelligence Act, non-EU providers of high-risk AI systems must appoint a legal representative established in the EU. This representative is responsible for ensuring compliance with the AI Act and serves as the EU-facing contact point for authorities.

Our EC-Rep service provides a fully compliant, reliable, and responsive regulatory presence in the EU—ensuring your products remain legally placed and continuously supported on the European market.