- 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 (Regulatory/Quality Management Information Source) has been a trusted partner for companies navigating the complex regulatory landscapes of the medical device, pharmaceutical, nutraceutical, and cosmetic industries worldwide.
With offices in Boston (USA), Barcelona (Spain), and London (UK), RQMIS is strategically positioned to support clients in achieving efficient global commercialization and regulatory success.
What RQMIS Actually Is
RQMIS (Regulatory/Quality Management Information Source) is a global regulatory consulting firm focused on helping life sciences companies get products to market—and keep them there.
They work across:
- Medical devices
- Pharmaceuticals
- Biotechnologies
- Combination products
- Nutraceuticals & cosmetics
What We Do (Core Capabilities)
1. Regulatory Strategy & Submissions
- FDA, EU, UK, and global regulatory pathways
- 510(k), De Novo, PMA, and international submissions
- Global market access and lifecycle regulatory strategy
- Initial Importer services and U.S. market entry support
2. Clinical Study Design & Management
- Protocol and investigational plan development
- Clinical operations and site management
- Data management, analysis, and reporting
- Post-Market Surveillance (PMS) and Phase IV studies
3. Quality Systems, Compliance & Product Lifecycle Support
- ISO 13485, FDA QSR (21 CFR 820), and global standards
- Audit readiness, remediation, and CAPA implementation
- Cybersecurity, software development, and validation/testing (including SaMD)
- Insurance reimbursement strategy and market access support
In short: RQMIS supports the full lifecycle—from concept and development → regulatory approval → post-market performance and commercialization.
What Makes Us Different
They position themselves less as “consultants” and more as embedded partners:
- Build end-to-end strategies, not just documents
- Combine regulatory + clinical + quality (most firms split these)
- Step in as outsourced departments when companies lack internal teams
That’s why a lot of their case studies look like: “we replaced your entire regulatory/clinical function overnight.”
Our Core Mission
Help companies:
- Get through regulatory approval faster
- Avoid costly missteps (failed submissions, audits, etc.)
- Stay compliant after launch
Or more bluntly: Reduce time-to-market and regulatory risk.
Global Footprint
- 🇺🇸 USA (Massachusetts HQ)
- 🇬🇧 United Kingdom
- 🇪🇸 Spain
This allows them to support FDA + EU + UK regulatory pathways simultaneously.
RQMIS isn’t trying to be everything—they’re focused on one thing:
getting complex, regulated products across the finish line without drama.
If a company:
- Has no internal RA/QA team
- Is stuck with the FDA
- Is scaling globally
- Or is cleaning up a mess
…this is exactly where they fit.
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
- US Agent & FDA Official Correspondent
- Small Business Certification (SBD) Submission
- Initial Importer
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