Gloster Biomedical International
YDE Biomed Consulting offers medical device expertise from concept through FDA approval, with 30 years of experience in the biomedical industry. Their mission is to accelerate FDA approval and market introduction for clients by guiding global clinical and regulatory strategies, preparing successful FDA submissions, and providing tools for growth. They aim to be a trusted resource for regulatory, quality, and medical device operations, ensuring compliance and success in FDA regulatory processes.
Industries
Nr. of Employees
small (1-50)
Gloster Biomedical International
Santa Barbara, California, United States, North America
Services
Tailored regulatory strategy development for medical devices and combination products to align clinical, regulatory and commercialization plans.
Compilation and preparation of FDA submissions including Q-Sub, IDE, 510(k), PMA, 513(g), RFD filings, and responses to deficiency letters.
Assistance with preparing clinical study submissions and regulatory reporting required for device approval processes.
Advisory services on regulatory quality systems and medical device operations to support compliance and regulatory submissions.
Tailored regulatory strategy development for medical devices and combination products to align clinical, regulatory and commercialization plans.
Compilation and preparation of FDA submissions including Q-Sub, IDE, 510(k), PMA, 513(g), RFD filings, and responses to deficiency letters.
Assistance with preparing clinical study submissions and regulatory reporting required for device approval processes.
Advisory services on regulatory quality systems and medical device operations to support compliance and regulatory submissions.
Expertise Areas
- Medical device regulatory strategy
- FDA submission preparation and review pathways
- Clinical study submissions and reporting
- Quality management systems for medical devices
Key Technologies
- Regulatory submission pathways (510(k), PMA, IDE, 513(g), Q-Sub)
- Software as a Medical Device (SaMD)
- Clinical study submission workflows
- Quality management systems (QMS) for medical devices
News & Updates
Client Testimonial - Morris
YDE Biomed Consulting is praised for FDA submissions, clinical study submissions, and regulatory success, with a team experienced in compliance and FDA interactions.
Client Testimonial - Guillaume
Guillaume highlights Catherine's pivotal role in FDA 510(k) application for Software as a Medical Device, emphasizing her guidance and documentation expertise.
Client Testimonial - Tom
Tom appreciates Catherine's leadership and guidance in complex projects across device and pharma areas, noting her clear, fact-based advice.
Client Testimonial - Morris
YDE Biomed Consulting is praised for FDA submissions, clinical study submissions, and regulatory success, with a team experienced in compliance and FDA interactions.
Client Testimonial - Guillaume
Guillaume highlights Catherine's pivotal role in FDA 510(k) application for Software as a Medical Device, emphasizing her guidance and documentation expertise.
Client Testimonial - Tom
Tom appreciates Catherine's leadership and guidance in complex projects across device and pharma areas, noting her clear, fact-based advice.