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Affidavit Of Conformity
"I need an Affidavit of Conformity for my medical device manufacturing company in Singapore, confirming that our new product line complies with ISO 13485:2016 standards, to be submitted to HSA by March 2025."
1. Title and Caption: Identifies the document as an Affidavit of Conformity and includes case reference if applicable
2. Deponent Information: Personal details of the person making the affidavit including full name, NRIC/Passport, occupation, and address
3. Statements of Truth: Numbered paragraphs containing the sworn statements regarding conformity
4. Verification Statement: Standard declaration of truth and accuracy of the statements made
5. Execution Block: Space for signature, date, and commissioner for oaths authentication
1. Preliminary Matters: Additional context or background information when needed for clarity - used when complex background information is necessary
2. Supporting References: Citations to relevant documents or regulations - used when specific standards or regulations are being confirmed
3. Qualification Statement: Details of deponent's expertise or authority - used when professional qualifications are relevant to the conformity statement
1. Exhibit List: Index of attached supporting documents
2. Technical Specifications: Detailed specifications or standards being conformed to
3. Supporting Documents: Copies of relevant certificates, test results, or other evidence of conformity
Authors
Authority
Certificate of Conformity
Commissioner for Oaths
Compliance Requirements
Conformity Assessment
Deponent
Document Reference Number
Effective Date
Governing Authority
Inspection Body
Jurisdiction
Product Specifications
Quality Management System
Regulatory Requirements
Relevant Standards
Required Specifications
Subject Matter
Technical Documentation
Testing Procedures
Verification Process
Professional Qualifications
Authority to Make Statements
Subject Matter Identification
Conformity Statements
Standards Compliance
Testing Methodology
Verification Process
Documentation References
Certification Status
Quality Assurance
Technical Specifications
Regulatory Compliance
Authentication
Truth and Accuracy
Supporting Evidence
Document History
Inspection Results
Assessment Procedures
Verification of Facts
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