About RQMIS

• 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

• 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

• Lasers
• Hearing Aids 
• Cochlear Implants

• Stents (bare metal and drug-eluting)
• Defibrillators
• Ablation Systems
• Cardiac Bio Prosthesis/Valve Replacement
• Catheters
• Tissue Regeneration

• HPV diagnostic product
• Detecting Biomarkers in Humans
• Infectious Disease Progenitor Monitoring
• In-situ Device to measure metabolic activity of tumors

• Dental Implants
• TMJ Implants
• Bone Filling/Augmentation Materials
• Dental Restorative Materials
• Orthodontics
• In-situ Detection of Oral Cancer

• 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

• Advance Therapy Medicinal Products (ATMP)
• Drug/Device/Biologic Combination

• Clinical laboratory testing
• Near-patient testing
• Self-testing

3D Printing Manufacturing 

• Spinal Implants
• Total Joint Prosthetics
• Bracing

Machine Learning/AI 

• Stroke Detection Devices
• Pulmonary Measurement Device
• Hemorrhage Detection Device

• The overall integration of Regulatory/Clinical/Quality Processes/Functions into business processes
• Acquisition Due Diligence – Regulatory/Clinical/Quality Focus
• Product Management of Spinal Implants

• 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

• CE Marking
• UKCA Marking
• Clinical Evaluation Reports
• Medical Device Authorized Representatives (EUAR)
• Medical Device Responsible Person (UKRP)
• Postmarket Surveillance

• 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

• 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

• 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

• 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