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U.S.A.
F.D.A. Regulatory Hands-on Help
Good
Manufacturing Practices (GMP) requirements promulgated under section 520
of the Food, Drug and Cosmetic (FD&C) Act.
The QS regulation
Part 820 of Title 21 of the Code of Federal Regulation
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 Classification,
Exemptions & Equivalence:
 | GMP
exemptions
| Device
classification
| Substantial
equivalence
| Statement
of Intended Use. |
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Site
Registration
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Quality
Manual Drafting New or Re - writing your existing Q.M.S.
| Compliance
with FDA cGMP
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Jointly compliant with the Medical Devices Directive, other EU
Directives, EN/ISO9000 -2000, EN46000
| Help
with the elements & of your quality management system: |
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Quality management
& organisation
Device design
Buildings
Equipment
Purchase & handling of components
Production & process controls
Packaging & labelling control
Device evaluation
Distribution
Installation
Complaint handling
Corrective & Preventive Action
Servicing
Training – including awareness of defects and errors
Records – Standard Operating Procedures, Device Master Records,
Device History File, documentation.
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Procedures - Improving & writing new Procedures
& Site Work Instructions.
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Design Controls
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Document Controls
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Purchasing Controls
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Identification and Traceability
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Production and Process Controls
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Acceptance Activities
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Non conforming Product
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Corrective and Preventive Action
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Handling, Storage, Environmental Control, Distribution,
and Installation
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Packaging and Labeling Control
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Records
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Servicing
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Statistical Techniques
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Flexibility
of GMP & Utilising it:
| Implementation
where appropriate
| Demonstrating
the appropriate quality system to control design, production &
distribution of the device
| Verification
and validation
| Critical
components and operation s / processes
| Justification
for non implementation |
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Technical
Files & Records:
| Standard
Operating Procedures
| Device
Master Record / File
| Device
History File
| Content:
What must be included,
| Device
Changes: How to manage product changes with cross references,
| New
Devices: How to add New Devices & when to file new submissions.
| Quality
system record
| Device
tracking & control number
| Other
documentation |
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Design Control:
820.30(a) General Regulatory Requirements
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manufacturer of any class III or class II device, and the class I
devices listed in paragraph (a)(2) of the above section, shall
establish and maintain procedures to control the design of the
device in order to ensure that specified design requirements are
met.
| Design
Input
| Design
Output
| Design
Review
| Design
Verification
| Design
Validation
| Design
Transfer
| Design
Changes
| Design
Control Objectionable Conditions & Discussions with Management |
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Software
Verification & Validation: including Year 2000 Compliance.
| Principles
of Software Validation & Validation Considerations
 | Software
Life Cycle Activities
Design Reviews
Validation Tasks: Management, Requirements, Design,
Implementation (Coding), Integration and Test. |
| Installation
Testing
| Maintenance
& Software Changes |
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Complaints:
| Complaint
Handling System
| Complaint
Responsibility
| MDR
Reportable Complaints
| Complaint
Records
| Investigation
Records
| File
Accessibility and Location
| Non
medical Complaints
| Complaint
Analysis
| Device
Failure Analysis
| Feedback
for QA System
| Complaint
Sources
| Medical
Device Reporting:
| Who
Must Report
| When
to Report
| Individual
Adverse Event Reports
| Written
MDR Procedures
| MDR
Event Files
| How
to Maintain MDR Event Files |
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Auditing
| Auditing
the quality system
| Correcting
deficiencies in the quality system
| Training
of auditors
| Preparing
for an FDA Inspection. |
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.510(k)'s
| Confirmation
of conformity route 510(k)
| Identification
of reviews of cleared 510(k)'s for suitable reference (predicate)
device.
| Guidance
on reviewing & drafting of 510(k)'s using information, data and
procedures, reports etc.
| Examine
critical experience data for proposed device model.
| Confirm
FDA classification for the device. |
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IDE's:
Full support from our US Specialists
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PMA's :
Detailed hands-on help provided
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Inspection
Support: Our specialists will guide your staff through each type of
inspection:
| Pre-Inspection
Activities
| Site
Inspections
| 510(k)
Device Inspections
| PMA
Device Inspections
| Electronic
Product Radiation Producing Devices Inspections
| Critical
Devices Inspections
| Automatic
Detentions |
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