Regulatory Sustenance

Sustaining Compliance Across the Lifecycle

Regulatory sustenance ensures ongoing compliance and product continuity across the device lifecycle. We enable this through DHF remediation, QMS alignment, and continuous regulatory maintenance. SJML helps OEMs sustain compliance while ensuring uninterrupted product continuity.

As regulations evolve, we support manufacturers to update documentation, manage changes, and stay aligned with standards like ISO 13485 and FDA requirements. Gaps in documentation or delayed CAPAs can disrupt market access and product viability, making a proactive, audit-ready approach essential.

Our Capabilities

Design History File (DHF) Remediation

Gap assessment and remediation planning
Documentation review and restructuring
Risk, design, and usability file alignment
Support across design and post-market phases

QMS Implementation & Remediation

QMS setup aligned to ISO 13485 and FDA requirements
Gap assessments and structured remediation plans
Documentation framework development and updates
Lifecycle quality system management and governance

ISO 14971 Risk Management

Risk analysis and control definition

Gap assessment of existing risk files

Risk management file development

Post-market risk updates and monitoring

CAPA Management

Root cause analysis and risk evaluation

CAPA planning, execution, and tracking

Verification and effectiveness checks

QMS-integrated CAPA workflows

Labeling Compliance

Global labeling strategy development

Label content customization and updates

IFU, eIFU, and patient information creation

UDI and traceability compliance management

Packaging Validation

Packaging design, material qualification, and sterile barrier validation
Process validation aligned with ISO 11607
Integrity, performance, and shelf-life (aging) testing
Distribution simulation (ISTA/ASTM) with complete validation documentation

Partner with Us to Help You Achieve Compliance Throughout Your Product Lifecycle

Engage early with regulatory experts to reduce audit risks, maintain compliance, and ensure uninterrupted global market access.