Helping Medical Device Companies Navigate Compliance and Market Entry
SeerPharma supports medical device organisations of all sizes — from start-ups to multinationals — with expert guidance across Quality Assurance (QA) and Regulatory Affairs (RA). Our team helps you build robust systems, achieve compliance, and accelerate your pathway to market.
Regulatory Strategy & Market Roadmap
A clear regulatory strategy is critical for determining device classification, the optimal pathway to market, and the milestones to track along the way. Our services include:
- Development of regulatory strategies for the US, EU, and Australian markets
- Preparation of technical documentation for regulatory submissions
- Validation studies to compile technical dossiers and demonstrate QMS compliance
- Guidance on clinical partnerships and validation approaches
- QA/RA support for clinical testing and data analysis
Market Entry & Conformity Assessment
Ensuring readiness for regulatory submission and approval is key to a successful product launch. We can help with:
- Reviewing and guiding completion of technical dossiers
- Supporting Conformity Assessment application processes
- Providing QA/RA support during regulatory preparations and audits
- Reviewing marketing materials for compliance
Quality Management Systems (QMS)
Build or strengthen your QMS to meet global standards and regulatory expectations. We offer expertise across:
- ISO 13485:2016
- ISO 14971:2019 (Risk Management)
- IEC 62304:2015 (Medical Device Software)
- ISO 15189:2022 (Medical Laboratories)
QA Oversight for Sub-Contractors & Vendors
We monitor and assess subcontractor and supplier performance to safeguard GMP compliance.
Training in QA/RA for Medical Devices
Customised training programs for your teams, including:
- QMS for Medical Devices (ISO 13485:2016)
- Risk Management (ISO 14971)
- Software as a Medical Device (SaMD)
- MDSAP, MDR, IVDR requirements
Mock Regulatory Audits
Prepare for real inspections with simulated Notified Body and regulatory audits. Our audits highlight gaps and provide actionable improvements to strengthen compliance before official assessments. Learn more.
