- Hemodialysis Systems
- Radiofrequency and Irreversible Electroporation
- Endoscopy/Laparoscopy/Bronchoscopy and Accessories
- Minimally Invasive Surgical Instruments/Implants
- Biliary Stents
- Ultrasonic Imaging
- Ostomy Devices/Accessories
Since 1996, RQMIS has been providing companies with strategic guidance on how to effectively navigate regulations in the US, the Americas, Europe, the Middle East and Asia.
Our regulatory consultancy team focuses in areas including regulatory strategy and submissions, clinical study design and management, quality systems design and compliance, and regulatory and quality system due diligence supporting business development and collaboration analyses
RQMIS has experience in the Medical Device, In Vitro Diagnostic (IVD), and Biotechnology industries; Regulatory, Clinical and Quality Affairs; Product Management and Operations. Senior management experience includes biomedical engineering, as well as experience as an FDA Senior Scientific Reviewer in the Agency’s CDRH and ODE Boston District offices.
Senior consultant experience comprises expertise in a broad
range of medical, laboratory and government relations areas including
medical devices and IVD, biologics and toxicology. Other experience
includes midlevel and executive management positions working for and
teaming with small start-ups, large medical device companies,
multinational businesses, and the US military and Homeland Security for
adoption of novel technologies. Markets include United States (including
Puerto Rico), European Union, South America, Canada, Mexico, Japan,
Israel, China and South Korea.
In addition to full time staff, RQMIS has a network of subcontractors with specialized experience in EU/US Medical Device/Human Tissue regulations and EU/US pharmaceutical/biological regulations. We have clinical monitors/project managers under contract in the US and outside the US; for example, Europe, Israel and Asia.
This intellectual database of resources allows us to design teams to support our clients’ project needs globally.
RQMIS Expertise By Market Segment
All Device Classes - I-III, Active Implantables and Human Tissue
Gastroenterology/Urology/Pulmonology/Plastic Surgery/Cardiology
Oral/Maxillofacial/Dental
- Dental Implants
- TMJ Implants
- Bone Filling/Augmentation Materials
- Dental Restorative Materials
- Orthodontics
Combination Products
- Advance Therapy Medicinal Products (ATMP)
- Drug/Device/Biologic Combination
IVD
- Clinical laboratory testing
- Near-patient testing
- Self-testing
RQMIS Expertise By Business Support Services
Business Management
- Overall integration of Regulatory/Clinical/Quality Processes/Function into business processes
- Acquisition Due Diligence – Regulatory/Clinical/Quality Focus
- Product Management of Spinal Implants
Regulatory - United States
- FDA Negotiations
- Premarket Notifications (510(k)) – Including Notes to File
- Investigational Device Exemptions (IDE) and Supplements
- Premarket Approval Applications (PMA) and Supplements
- Labeling/Promotional Materials Review
- Registration and Listing
Regulatory - Rest of World
- Premarket Submissions
Quality
- ISO 13485 Quality System Design/Compliance/Auditing
- FDA QSR and Human Tissue GMP Design/Compliance/Auditing
- FDA Negotiations/Responses to 483’s, Warning Letters and Recalls
Clinical
- Overall Clinical Study Management – phase II, III and Post Marketing Surveillance
- Study setup and CA/IRB/EC submissions
- Protocol Management in the US, EU, Israel, Brazil, Turkey, and South Africa
- Clinical Affairs Process Development and Procedures
- Study Monitoring
- Developed/Managed Data Safety Monitoring Boards
- Clinical Report Writing
- Protocol design/development
- Case Report Form design/development
- Insurance Reimbursement
- Bioresearch Monitoring