About Highland Biomedical
Dedicated to helping medical device companies bring innovative healthcare technologies to market.
Our Mission
We believe that innovative medical devices should reach patients without unnecessary delays. Our mission is to provide expert regulatory guidance, quality systems support, design and development support, and strategic consulting that accelerates the path from concept to commercialization while ensuring full compliance with targeted regulatory requirements.
Our Expertise
Regulatory Affairs
- FDA 510(k), De Novo, and PMA submissions
- CE marking and EU MDR compliance
- Health Canada and global market approvals
- Regulatory strategy development
- FDA pre-submission meetings and correspondence
Quality Systems
- e-QMS identification and implementation
- ISO 13485 implementation and maintenance
- Design controls and risk management
- Non-Conformance and CAPA
- Supplier management and auditing
Product Development
- Development strategy and feasibility
- Risk management per ISO 14971
- User-centered design per IEC 62366
- Verification, validation, and design transfer
- Manufacturing scale-up support
Medical Device Software
- SaMD and SiMD regulatory pathways
- Software lifecycle per IEC 62304/TIR45
- Software risk classification and categorization
- Algorithm validation and GAMP5
- Pre-market software documentation
Cybersecurity
- FDA cybersecurity guidance and TIR57
- Threat modeling (STRIDE) and risk assessment
- SBOM generation and management
- Secure product development frameworks
- Post-market vulnerability management
Post-Market Surveillance
- PMS plan development and maintenance
- Adverse event management and vigilance reporting
- PMCF study design
- Real-world evidence generation
- Field actions and market corrections
Industry Focus
Diagnostic & Monitoring Equipment
Surgical Instruments & Robotics
Digital Health & SaMD/SiMD
Pharmaceutical Combination Products
In-Vitro Diagnostics
Implantable Devices
Our Commitment
E
Excellence
Delivering high-quality regulatory submissions and strategic guidance.
E
Efficiency
Streamlining processes to reduce time-to-market.
P
Partnership
Building long-term relationships with our clients.
I
Innovation
Supporting breakthrough technologies that improve patient outcomes.