Regulatory strategy & pathway planning
- Target-market and pathway assessment
- Device classification support
- Regulatory roadmap and gap assessment
- Applicable standards and evidence mapping
- Regulatory change-impact review
Service catalogue
Regulatory services across the product lifecycle.
From early regulatory planning and manufacturing-site readiness to licensing submissions, technical documentation, audit preparation, and post-market obligations.
Facility & site readiness
- Site readiness gap assessment
- Manufacturing-flow and documentation review
- QMS and facility evidence checklist
- Equipment and process documentation planning
- Inspection / audit preparation support
Licensing & regulatory submissions
- Application dossier preparation support
- Document compilation and consistency checks
- Submission tracker and deficiency response coordination
- Regulatory correspondence support
- License maintenance and change assessment
Technical documentation
- Device description and intended purpose
- GSPR / Essential Principles checklists
- Technical file / dossier structure
- Labeling, IFU and UDI documentation support
- Traceability and evidence indexing
Quality Management System
- ISO 13485 documentation and gap reviews
- SOPs, forms, records and document control
- Internal audit preparation
- CAPA, nonconformity and change control
- Management review and quality objectives
Design & risk management
- Design and development file support
- Design inputs, outputs and traceability
- DFMEA / risk analysis facilitation
- ISO 14971 risk management files
- Benefit-risk and risk-control traceability
Verification, validation & testing
- Validation master planning
- Equipment IQ/OQ/PQ documentation
- Process validation protocols and reports
- Packaging validation and shelf-life documentation
- Test method validation and verification support
Clinical evaluation & biological safety
- Clinical Evaluation Reports (CER)
- Literature search and screening
- Clinical evidence appraisal and equivalence documentation
- Biological evaluation planning support
- Clinical investigation documentation coordination
Post-market & lifecycle compliance
- PMS plans and reports
- PMCF planning and evaluation documentation
- PSUR support where applicable
- Complaint, vigilance and trend-reporting processes
- Periodic review and regulatory change assessment
Supplier & outsourced process controls
- Supplier qualification documentation
- Quality agreements and supplier evaluation tools
- Incoming inspection and supplier monitoring
- Outsourced process controls
- Supplier corrective action tracking
Audit & certification readiness
- Pre-audit gap assessment
- Audit evidence room / index preparation
- Finding response and CAPA documentation
- MDSAP readiness support
- Certification-body interface preparation
Training & ongoing support
- Regulatory and QMS awareness training
- Document owner coaching
- Fractional regulatory / quality support
- Compliance calendar and action trackers
- Periodic file and procedure reviews
Scope note: Services are consulting and documentation support. Actual site installation, testing, certification, clinical investigations, laboratory work, notified-body decisions, and government license approvals may require authorized third parties or competent authorities. No approval outcome is guaranteed.
Need an end-to-end work plan?
We can discuss your product, site status, target markets, and the specific activities you want support with.