Regulatory Pathways
Consultancy providing regulatory, clinical, quality, statistical, medical writing, scientific and technical support to medical device, biologic and pharmaceutical developers. Services include regulatory strategy and submissions (US FDA and EU MDR), clinical trial design and execution, quality system implementation, post-market surveillance, and specialist technical support across areas such as sterilization, microbiology, software verification, and photonics-based devices.
Industries
Nr. of Employees
small (1-50)
Regulatory Pathways
Orange, California, United States, North America
Services
End-to-end development of regulatory strategies and preparation/management of submissions to regulatory authorities.
Protocol development, ICFs, CRFs, investigator training, IRB/EC submissions and clinical study management.
Statistical planning, SAP development, sample size calculations, database design/validation and analysis.
Design and implementation of QMS, SOPs, MDSAP preparation, supplier quality audits and inspection readiness.
Usability testing, IFU development, labeling artwork and UDI/GUDID registration support.
Oversight of sterilization, biocompatibility, electrical safety, EMC, preclinical testing and photonics/laser device testing.
End-to-end development of regulatory strategies and preparation/management of submissions to regulatory authorities.
Protocol development, ICFs, CRFs, investigator training, IRB/EC submissions and clinical study management.
Statistical planning, SAP development, sample size calculations, database design/validation and analysis.
Design and implementation of QMS, SOPs, MDSAP preparation, supplier quality audits and inspection readiness.
Usability testing, IFU development, labeling artwork and UDI/GUDID registration support.
Oversight of sterilization, biocompatibility, electrical safety, EMC, preclinical testing and photonics/laser device testing.
Expertise Areas
- Regulatory strategy and submissions (US FDA and EU MDR)
- Clinical trial design and management
- Statistical analysis and data management
- Quality systems and compliance (FDA QSR, ISO 13485, MDSAP)
Key Technologies
- Clinical study design and CRF development
- Statistical analysis and SAS programming
- Software verification and validation
- Cybersecurity threat assessment and modeling
News & Updates
Consultancy participation in approved IDE studies for a range of devices including ophthalmic implants, laser systems and glaucoma implants.
Assisted with 510(k) clearances for novel and digital diagnostic/monitoring devices, surgical instruments, lasers and ocular therapeutics.
Participation in successful Class II De Novo petitions for novel device types including home-use diagnostic devices and neurostimulation devices.
Support for premarket approval applications and orphan device (HUD/HDE) designations for first-of-a-kind ophthalmic and implantable devices.
Consultancy participation in approved IDE studies for a range of devices including ophthalmic implants, laser systems and glaucoma implants.
Assisted with 510(k) clearances for novel and digital diagnostic/monitoring devices, surgical instruments, lasers and ocular therapeutics.
Participation in successful Class II De Novo petitions for novel device types including home-use diagnostic devices and neurostimulation devices.
Support for premarket approval applications and orphan device (HUD/HDE) designations for first-of-a-kind ophthalmic and implantable devices.