Address
6F.-3, No.371, Sec. 1, Guangfu Rd., East Dist., Hsinchu City 30074, Taiwan (R.O.C.)
Contact
Tel：+886-3-666-0139
Fax：+886-3-666-0149
Email: services@seqpro.com.tw
Premarket Submission
Gap Analysis on Regulatory Compliance of Safety-Related Technical Documents
- Gap analysis on electrical safety and EMC related hazards and risks based on IEC 60601-1, IEC 60601-1-2 and post-market information within FDA regulatory database, conduct research on electrical safety and EMC-related hazards and risks in product technical documents and evaluate test items.
- Gap analysis on biocompatibility-related hazards and risks based on ISO 10993-1, FDA regulatory guidelines and post-market information within FDA regulatory database, conduct research on biocompatibility-related hazards and risks in product technical documents and evaluate test items.
- Gap analysis on usability-related use error based on IEC 62366-1, FDA regulatory guidance and post-market information within FDA regulatory database, conduct research on use error and risks and evaluate test items.
- Gap analysis on software-related hazards and risks, and evaluation of design verification and validation items, based on IEC 62304, IEC 82304, FDA regulatory guidance and post-market information within FDA regulatory database, conduct research on software-related hazards and risks in product technical documents and evaluate test items.
- The evaluation scope includes the following but is not limited to: intended use/clinical indications, software level of concern description, system/software architecture, software verification and validation plan, software verification and validation report (including unit, integration, system level testing records), software maintenance documents, software configuration management documents, unresolved software failures and risk control measures, software failure assessment and risk control measures, validation of AI/ML related software algorithm input/output medical association, analysis performance validation protocol and report, clinical performance validation protocol and reports, etc.
- Gap Analysis on cybersecurity-related threats, vulnerabilities and risks, and evaluation of design verification and validation items, based on FDA regulatory guidance and post-market information within FDA regulatory database, conduct research on cybersecurity-related threats, vulnerabilities, and risks in product technical documents, and evaluate test items.
Gap Analysis of Regulatory Compliance of Performance-Related Technical Documents
- Gap analysis on preclinical product performance evaluation and test report according to state-of-the-art technology, for example verification based on the preclinical product performance test standards proposed by the team and the performance comparison test results of predicate devices
- Gap analysis on clinical perf evaluation and clinical trial according to state-of-the-art technology, for example product-specific regulatory guidance, performance comparison results of predicate devices, and clinical guidance (if any).
Consolidation of Design and Development Related Documents and Records
- Consolidation of clinical safety and perf evaluation, and testing information, including literature review and product comparison results (versus predicate and reference device).
- Consolidation of benefit-risk evaluation information including related risk control evidence.
- Consolidation of design history file (DHF), according to quality system regulation of the target market, with contents including but not limited to:
- Design and development plan
- Design input
- Design output
- Design verification records, including safety evaluation and testing reports
- Design validation records, including performance evaluation and testing reports
- Design changes records
- Design transfer records
- Risk management plan
- Risk management records
- Process validation plan
- Process validation reports
- Equipment/instrument management records
- Consolidation of device master file (DMR), according to quality system regulation of the target market, with contents including but not limited to:
- Device Specification:
- Materials, component specifications
- Drawings or Prints
- Bill of Materials
- Mechanical Requirements
- Product Performance Specifications
- Software Specifications
- Risk Management:
- Risk management policy
- Risk Management Plan
- Risk Hazard Analysis/Report
- Risk Management Summary
- Production and Process Specifications:
- Equipment specifications and operating instructions
- Production methods or procedures
- Production environmental specifications
- Quality Control Specifications:
- Quality Control procedures and test methods
- Quality Control equipment instructions, calibration and maintenance specifications and operating instructions
- Accept/Reject criteria, including authorization for release
- Packaging and Labeling Specifications:
- Package specifications
- Label specifications
- Label and labeling master copies
- Unique Device Identification (UDI)
- Methods and processes used for label control and application
- Environmental:
- Microbial or cleanliness requirements
- Shelf-life or expiration dating
- Temperature storage specifications
- Shipping temperature specifications
- Installation, Maintenance and Service Requirements:
- Installation and inspection instructions and procedures
- Maintenance Procedures and Methods
- Servicing and inspection instructions and procedures
- Service report and analysis procedures, and statistical methods
- Consolidation of risk management file (RMF), according to quality system regulation of the target market, with contents including but not limited to:
- Risk management plan
- Hazard and risk analysis
- Risk evaluation
- Risk control measures and implementation
- Effectiveness of risk control measures
- Residual risk evaluation
- Overall benefit-risk evaluation
- Post-market risk evaluation plan