- Spinal Implants—Total/Partial Disc Replacement, Facet Replacement, Nucleus Replacement, Fusion Constructs
- Bone Replacement Materials—Human Tissue/Synthetics/ Biologics (peptides, stem cells)
- Internal/External Bone Growth Stimulators—Active Implantable
- Sports Medicine
- Paediatrics Skeletal Reconstruction
- Hyaluronic Acid
- Total Joint Prosthetics
- External and Internal Trauma Implants
- Bracing
- Diazepam
- Antibiotic Bone Cement
Our mission is simple: Get our clients' products to market, and keep them there.
Since 1996, RQMIS has been providing companies with strategic guidance on how to effectively navigate the medical device, pharma, nutraceutical, and cosmetics regulations all around the globe. RQMIS currently has company locations in Boston (US), Barcelona (EU), and in London (UK).
RQMIS stands for "Regulatory/Quality Management Information Source". Our team of consultants is led by a former FDA reviewer from the Office of Device Evaluation, Boston district. Our regulatory consultancy focuses on four principal areas: Regulatory Strategy and Submissions, Clinical Study Design and Management, Quality Systems Design and Compliance, Insurance Reimbursement, Postmarket Surveillance, and Cybersecurity.
We operate as a family business, meaning our clients are always our first priority. We understand the frustration and confusion that comes with navigating the regulatory "red tape" which is why we're always available to our clients. We're not too busy to answer a phone call, email, or make an in-person visit. RQMIS is in this with you, and at the end of the day, we want to see you and your product succeed.
Our goal is always the same - to execute the most efficient and cost-effective commercialization pathway for our clients worldwide. We like to say we're a "one-stop-shop", offering not just Regulatory solutions but Quality and Clinical as well. Rather than educating our consultants on a wide range of specialties we prefer to work with a larger team where each person has their niche that they are expertly trained in. This means you're always getting 110% when you work with us.
We are proud to have a team from a wide range of backgrounds including SaMD, AI, cardiology, orthopedics, pharmacy, cosmetics, and nutrition in the veterinary and environmental fields.
If you are an expert consultant join the RQMIS family!
RQMIS Expertise By Market Segment
All Device Classes - I-III, Active Implantables, and Human Tissue
Musculoskeletal
Gastroenterology/Urology/Pulmonology/Plastic Surgery
- Hemodialysis Systems
- Radiofrequency Ablation and Irreversible Electroporation
- Endoscopy/Laparoscopy/Bronchoscopy and Accessories
- Minimally Invasive Surgical Instruments/Implants
- Biliary Stents
- Ultrasonic Imaging
- Ostomy Devices/Accessories
- Sevoflurane
- Auto-Injector
- Picture Archiving and Capture Systems (PACS)
- Infusion Pumps
- Covid diagnostic test
- Ventilators
- Live bacteria for gut health improvement
- Live bacteria treating asthma symptoms
- Live bacteria for metabolic disorders
ENT
- Lasers
- Hearing Aids
- Cochlear Implants
Cardiology
- Stents (bare metal and drug-eluting)
- Defibrillators
- Ablation Systems
- Cardiac Bio Prosthesis/Valve Replacement
- Catheters
- Tissue Regeneration
Oncology
- HPV diagnostic product
- Detecting Biomarkers in Humans
- Infectious Disease Progenitor Monitoring
- In-situ Device to measure metabolic activity of tumors
Oral/Maxillofacial/Dental
- Dental Implants
- TMJ Implants
- Bone Filling/Augmentation Materials
- Dental Restorative Materials
- Orthodontics
- In-situ Detection of Oral Cancer
OB/GYNO/Metabolism/Dermatology
- Lubricants
- Laparoscopy and Accessories
- Blood glucose test
- Breath air ketones test
- Acne treatment
- Atopic dermatitis treatment
- Psoriasis treatment
- Hirsutism treatment
- Impetigo treatment
- Live bacteria for skin improvement
- Skin protection
Combination Products
- Advance Therapy Medicinal Products (ATMP)
- Drug/Device/Biologic Combination
IVD
- Clinical laboratory testing
- Near-patient testing
- Self-testing
Technology
3D Printing Manufacturing
- Spinal Implants
- Total Joint Prosthetics
- Bracing
Machine Learning/AI
- Stroke Detection Devices
- Pulmonary Measurement Device
- Hemorrhage Detection Device
RQMIS Expertise By Business Support Services
Business Management
- The overall integration of Regulatory/Clinical/Quality Processes/Functions into business processes
- Acquisition Due Diligence – Regulatory/Clinical/Quality Focus
- Product Management of Spinal Implants
Regulatory - United States
- FDA Negotiations
- Premarket Notifications (510(k)FDA) – Including Notes to File
- Investigational Device Exemptions (IDE) and Supplements for FDA
- Premarket Approval Applications (PMA) and Supplements for FDA
- Labeling/Promotional Materials Review
- FDA Medical Device Registration and Listing
Regulatory - EU / UK
- CE Marking
- UKCA Marking
- Clinical Evaluation Reports
- Medical Device Authorized Representatives (EUAR)
- Medical Device Responsible Person (UKRP)
- Postmarket Surveillance
Quality
- Internal Audits
- 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
- Postmarket Surveillance
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
Cybersecurity in Medical Devices
- Web and mobile application penetration testing
- Security and Information Event Management (SIEM) solutions
- Remote Security Operations Center Team (SOC) to work with your IT organization to rapidly detect, triage, and aid in the remediation of security incidents
- Consulting on cybersecurity requirements and best practices
Postmarket Surveillance
- Properly categorizing and processing customer/employee feedback, repair processing, complaints
- Serious injury/death reporting (e.g., MDR and Vigilance Reporting)
- Health Hazard Analysis/Reports
- Recalls
- Postmarket Clinical Follow-up (PMCF) Studies
- Review and analysis of published and unpublished clinical studies/experience
- Clinical Evaluation Reports
- Updating and maintaining the risk management profile of a family of products based on a comprehensive review of postmarketing data.
- Technical Documentation for CE Marking, including product labeling
- Trend analysis of Post Market data to determine the potential need for CAPAs
- Review of clinical experience to determine potential new uses of existing products