Regulatory Services
Regulatory Cleanup
- 483 and warning letter responses
- Consent Decree and/or Recall planning and response
- Corrective and Preventive Action (CAPA) plans
- Audit of your current quality system
Regulatory Approval & Clearance
- Quality System Management (QMS) setup, implementation and ongoing maintenance services
- US Clearance or approvals – 510(k), PMA, De Novo, IDE, HDE
- Service as US Agent for Foreign Manufacturers
- 21 CFR Part 820, 210 and 211
- CE Marking – Technical File preparation, classification determination, and Conformity Assessment
- Health Canada – Medical Devices Active License Listing (MDALL), Medical Device Establishment License (MDEL)
- ISO 13485 and ISO 9001 certifications
- MDSAP preparation services
Start-Up Company
- Project Planning
- Serve as QA Manager or Quality Engineer within your organization
- Develop and implement Quality Management System (QMS) including preparing related Standard Operating Procedures (SOPs), Forms, Work Instructions, etc.
- Provide regulatory plan assistance
- Provide least burdensome approach advice while minimizing start-up costs
Complaints, MDR, & MDV
- Develop your complaint, recall, and reporting SOPs and establish your processes
- Assist with review and evaluation of complaints to determine need for investigation, Medical Device Reporting (MDR) and/or Medical Device Vigilance (MDV)
- Assist with complaint trend and identify actions needed
- Temporary assistance for higher-than-normal complaint file handling needs
- Post-market surveillance and literature search
Other Services
Other Services
- Gap analysis against current Design History File and FDA documentation against other country regulations and requirements
- ISO 13485:2016 compliance
- Health Canada Medical Device Regulation SOR 98/282 compliance
- Assistance with MDSAP certification requirements
- European Union Medical Device Regulations (MDR 2017/745), formerly Medical Device Directive (MDD 93/42/EEC) compliance
- Medical Device Classification assistance
- Implementation of Global Harmonization Task Force (GHTF) and International Medical Devices Regulators Forum (IMDRF) guidance documents within your organization
Development Services
Risk Management
Verification, Validation & Engineering Support
Verification, Validation & Engineering Support
- Develop your Risk Management Standard Operating Procedures (SOPs) and establish your risk analysis process (ISO 14971)
- Assist with Risk Management Plan (RMP), Pre-Hazard Analysis (PHA), Fault Tree Analysis (FTA), Risk-Benefits Analysis (RBA), Failure Mode and Effect Analysis (FMEA), Risk Management Report (RMR), and others
- Independent reviewer with technical background to help provide a “second pair of eyes”
- Provide assistance with risk mitigation efforts
Verification, Validation & Engineering Support
Verification, Validation & Engineering Support
Verification, Validation & Engineering Support
- Develop your design and process verification and validation procedures, including equipment and calibration evaluation and maintenance
- Assistance with Master Validation Plan (MVP) preparation including process, product, equipment validation activities
- Assistance with Installation Qualification (IQ), Operational Qualification (OQ), Performance, Product and/or Process Qualification (PQ/PPQ), and Test Method Validation (TMV) activities including preparation of protocols and reports and execution, as applicable
Design Control
Verification, Validation & Engineering Support
Design Control
- Project Planning
- Develop your design control process including design planning, design input and output, design verification and validation, and design transfer
- Provide assistance with developing a traceability matrix between design inputs and outputs for clearer
- Assistance with Design for Manufacturability and design improvement
- Manufacturing transfer assistance
Quality Management Services
Nonconformance (NCMR, NCR)
Corrective and Preventive Action (CAPA)
Corrective and Preventive Action (CAPA)
- Develop your NCMR/NCR SOP and establish your process
- Assist with investigation, disposition, and CAPA assignment
- Assist with controlling and minimizing your nonconforming material and scrap rates
- Assist with determining and evaluating rework activities Determine need for a Planned Deviation SOP and provide guidance on Deviation usage
Corrective and Preventive Action (CAPA)
Corrective and Preventive Action (CAPA)
Corrective and Preventive Action (CAPA)
- Develop your CAPA SOP and establish your process
- Assist with investigation, root cause analysis, and effectiveness
- Assist with verification activities and CAPA trend analysis
Supplier Control
Corrective and Preventive Action (CAPA)
Supplier Control
- Develop your Supplier Control SOP and establish your process
- Conduct on-site supplier audits including audit report
- Assist with supplier verification activities
Training
Training
Supplier Control
- Training to Current Good Manufacturing Practice (cGMP), current Good Laboratory Practice (cGLP), FDA regulations, and ISO 13485
- Education assistance with FDA actions and inspections
- Training and workshops for general staff, technical staff, management, executives and line personnel
Audits
Training
Audits
- Supplier audits
- External audits
- Internal audits
- Gap analysis of your current QMS against ever-changing regulations and standards