FIDELIS Industry Technical Terms of Delivery for Surgical Instruments and Medical Equipment

Date: June 2025

1. Purpose and Scope

1.1. Purpose: This document delineates the comprehensive technical terms of delivery (TTD) that govern the quality, performance, and conformity of all surgical instruments and related medical equipment (hereafter referred to as “Products”) supplied to, or manufactured by/for, Fidelis Industry. Adherence to these terms is mandatory to ensure consistent, reproducible product quality meeting Fidelis Industry’s standards, regulatory obligations, and customer expectations.
1.2. Scope: These TTD apply to all internal manufacturing processes, as well as to external suppliers, sub-suppliers, and contract manufacturers providing components, semi-finished, or finished Products to Fidelis Industry. These requirements are supplementary to any product-specific drawings, specifications, or quality agreements. In case of any conflict, the product-specific documentation shall prevail unless explicitly stated otherwise herein.
1.3. Involved Fidelis Industry Entities:
- Fidelis Industry – Production & Development: Head Office, Marala Street, near Hassanwal, Sialkot, Pakistan. Telephone: +92 345 843 3233. Email: [Insert Production & Development Email Address – e.g., production.dev@fidelisindustry.com]
- Fidelis Industry – Marketing & Sales: Doha, Qatar. Telephone: +974 3336 6593. Email: [Insert Marketing & Sales Email Address – e.g., sales.qatar@fidelisindustry.com]
- Fidelis Industry – Software Development Division (as applicable to device interface/integration): Head Office, Marala Street, near Hassanwal, Sialkot, Pakistan. Telephone: +92 345 843 3233. Email: [Insert Software Development Email Address – e.g., software.dev@fidelisindustry.com]
- Fidelis Industry – IPS® Planning Division (as applicable to custom/patient-specific devices): Head Office, Marala Street, near Hassanwal, Sialkot, Pakistan. Telephone: +92 345 843 3233. Email: [Insert IPS® Planning Email Address – e.g., ips.planning@fidelisindustry.com]

2. Definitions and Abbreviations

DIN: Deutsches Institut für Normung (German Institute for Standardization)
EN: European Norm
EU: European Union
FI-TTD: Fidelis Industry – Technical Terms of Delivery
IPS®: Individual Patient Solutions
ISO: International Organization for Standardization
MDD: Medical Device Directive (93/42/EEC)
MDR: Medical Device Regulation (EU 2017/745)
Product(s): Surgical instruments and other medical equipment, components, or assemblies.
QMS: Quality Management System
TTD: Technical Terms of Delivery

3. General Requirements & Regulatory Compliance

3.1. The quality requirements stipulated herein are derived from prevailing market demands, international normative standards, and the legislative requirements of the EU Medical Device Regulation (2017/745), the Medical Device Directive (93/42/EEC), and pertinent national laws for medical devices in their most current versions.
3.2. Suppliers and internal manufacturing units shall operate under a robust QMS (e.g., ISO 13485 or equivalent, appropriate to the product classification and manufacturing activities).
3.3. All Products must comply with applicable general safety and performance requirements (GSPR) of the MDR.

3. General Requirements & Regulatory Compliance

3.1. The quality requirements stipulated herein are derived from prevailing market demands, international normative standards, and the legislative requirements of the EU Medical Device Regulation (2017/745), the Medical Device Directive (93/42/EEC), and pertinent national laws for medical devices in their most current versions.
3.2. Suppliers and internal manufacturing units shall operate under a robust QMS (e.g., ISO 13485 or equivalent, appropriate to the product classification and manufacturing activities).
3.3. All Products must comply with applicable general safety and performance requirements (GSPR) of the MDR.

4. Materials Specifications

4.1. Approved Materials: Only materials explicitly approved by Fidelis Industry and specified in relevant drawings or product master files shall be used. For surgical and dental instruments, these typically include, but are not limited to:
- DIN EN ISO 7153-1: “Surgical Instruments – Materials – Part 1: Metals”
- DIN EN ISO 21850-1:2020-08: “Dentistry – Materials for dental instruments – Part 1: Stainless steel”
- Other materials (e.g., polymers, ceramics, titanium alloys) must conform to specified ASTM, ISO, or equivalent standards as detailed in product-specific documentation.
4.2. Deviations: Any deviation from specified materials must be formally requested, justified, documented, and receive prior written approval from Fidelis Industry’s Production & Development department.
4.3. Material Integrity: Forged parts must be free from folds, laps, cracks, voids, and other metallurgical discontinuities detrimental to the product’s integrity or performance.
4.4. Hardness: Instrument hardness must conform to specifications in the relevant drawing or, if unspecified, to the applicable material standard (e.g., DIN EN ISO 7153-1). Hardness testing shall be conducted according to DIN EN ISO 6507-1 (Vickers), DIN EN ISO 6508-1 (Rockwell), or DIN ISO 3738-1, as appropriate.
4.5. Material Certification: Material test certificates (e.g., Type 3.1 according to DIN EN 10204) traceable to the heat/lot number must be provided for each batch of material/product and archived for a minimum of thirty (30) years post-delivery to Fidelis Industry or product obsolescence, whichever is later.

5. Dimensions, Tolerances, and Metrology

5.1. Adherence to Specifications: All Products must conform to the dimensions and tolerances specified in the official Fidelis Industry drawings and/or 3D CAD models.
5.2. Measurement Methods: Unless otherwise specified, measurement methods for basic dimensions of medical instruments shall be as defined in DIN 96298-2: “Medical Instruments – Part 2: Measuring methods for investigating the basic dimensions.” Product-specific standards or drawing specifications shall take precedence.
5.3. Calibration: All measuring equipment used must be calibrated and traceable to national or international standards.

6. Surface Finish and Cleanliness

6.1. General Surface Condition: Surfaces must be free of pores, cracks, pits, scratches, scores, grooves, burrs, sharp edges (unless functionally required), contamination (e.g., acidic fats, oils, fingerprints), and residues from manufacturing processes (e.g., grinding, polishing, cleaning agents).
6.2. Joints and Welds: Soldered, welded, or brazed joints must exhibit complete fusion, be free of porosity, open areas, or undercuts, and be smoothly finished.
6.3. Surface Finish Hierarchy:
1. As per the currently valid Fidelis Industry drawing.
2. As per the currently valid Fidelis Industry internal document: D00000000600 – WI Specifications for surface finish of surgical & dental instruments (or its superseding version). [Note: Please verify and update this internal document reference if different.]
3. If options 1 or 2 are not feasible due to geometric constraints, an alternative finish must be proposed, justified, and formally approved, with such approval documented in the technical drawing.
6.4. Roughness: To ensure quality, the surface roughness (Ra) shall be measured transverse to any brushing or grinding direction. Unless otherwise specified, Ra must be ≤0.5μm. Specific requirements for different surface types (e.g., matte, polished, coated) will be detailed in the aforementioned document D00000000600 or product drawings.
6.5. Passivation: All stainless steel instruments must undergo appropriate passivation processes to ensure optimal corrosion resistance, with records maintained.

7. Key Quality & Functional Criteria

7.1. General Condition: All instruments must be delivered free of oil residues from production (other than specified lubricants), stains, traces of corrosion, and any other impurities or damages. Working ends must be fully functional for their intended surgical or medical purpose.
7.2. Lubrication: Closing areas, joint areas, and movable parts of instruments requiring lubrication shall be treated with medical-grade paraffin oil or another Fidelis Industry-approved lubricant, applied sparingly.
7.3. Joints (e.g., Hinges, Pivots): Instruments with joints must exhibit a smooth, consistent, and steady movement (“gait”) without excessive play or stiffness.
7.4. Box Locks / Screw Locks: Locks must be meticulously clean, smooth, and precisely fitted. No scratches, grooves, or other damage should be visible. Screw and rivet connections must be secured to prevent independent loosening throughout the instrument’s validated lifecycle.
7.5. Ratchet Locks: Ratchets must be clean, with uniformly pronounced teeth over the entire functional profile. The ratchet mechanism must engage securely and shall not release automatically or unintentionally when closed under normal operating forces.
7.6. Working Ends / Tips: Functional elements (e.g., jaws, blades, tips) must be precisely formed, aligned, and finished according to the intended use. Serrations or tooth profiles must be burr-free, evenly symmetrical down to the tooth base, mesh accurately, and not snag or hook in any position.
7.7. Springs: Springs must provide uniform and sufficient force for their intended function (e.g., instrument resetting), maintaining their properties throughout the validated lifecycle.
7.8. Connections (e.g., Luer, Threaded): All connections must be dimensionally accurate, free of pores, cleanly processed, and undamaged, ensuring secure and leak-proof mating where applicable.
7.9. Edges: Sharp functional edges must be appropriately sharp, uniform, and free from defects. Non-functional edges must be deburred and smoothly broken to prevent injury or glove tearing, unless otherwise specified for functional reasons.
7.10. Form and Symmetry: Asymmetrical forms (unless intentionally designed), distortions, warpage, or unevenness (e.g., in shafts, handles) are not acceptable. The overall instrument must be manufactured in a formally correct, coherent, and ergonomically sound manner.

8. Marking and Identification

8.1. Products shall be marked in accordance with specifications on the drawing or relevant standards. Markings must be clear, legible, permanent, and resistant to normal reprocessing cycles.
8.2. Marking methods (e.g., laser etching, electrochemical etching) must not compromise the material integrity, corrosion resistance, or biocompatibility of the product.
8.3. Unique Device Identification (UDI) requirements, if applicable, must be met as specified.

9. Packaging and Delivery

9.1. Primary Packaging: Instruments must be individually packaged or appropriately segregated to prevent damage (e.g., scratches, impact) during handling, transit, and storage.
9.2. Protection: Sharp points, delicate features, or components posing an injury risk must be adequately protected (e.g., with tip caps, sleeves).
9.3. Identification: Outer packaging must clearly identify the contents, referencing the Fidelis Industry part number, batch/lot number, quantity, and any other required identifiers (e.g., purchase order number), aligning with drawing specifications.
9.4. Cleanliness at Delivery: Products must be delivered in a clean state, though not necessarily sterile unless explicitly contracted for as such.

10. Supplier Obligations & Quality Assurance

10.1. Adherence: The supplier/manufacturing unit is responsible for ensuring that all Products and manufacturing processes comply with these TTD and any referenced documents.
10.2. Inspection and Testing: The supplier shall perform adequate incoming, in-process, and final inspection and testing to verify conformity. Records of such activities shall be maintained and made available to Fidelis Industry upon request.
10.3. Change Control: Any proposed changes to materials, processes, or specifications must be submitted to Fidelis Industry for written approval prior to implementation.
10.4. Non-Conformances: Any deviation from the agreed specifications or these TTD must be immediately reported to Fidelis Industry for disposition. Non-conforming products shall not be shipped without prior written authorization from Fidelis Industry.

11. Documentation and Traceability

11.1. Full traceability of materials and critical manufacturing processes must be maintained and documented.
11.2. All relevant documentation (e.g., material certificates, inspection reports, certificates of conformity) must accompany shipments or be provided as agreed.

12. Confidentiality

All drawings, specifications, and information provided by Fidelis Industry shall be treated as confidential and shall not be disclosed to third parties or used for any purpose other than fulfilling Fidelis Industry’s orders, without prior written consent.

13. Review and Amendments

These TTD are subject to periodic review and amendment by Fidelis Industry. The version current at the time of order placement shall apply.

14. Acceptance

Receipt of a purchase order or commencement of work for Fidelis Industry implies acceptance of these Technical Terms of Delivery.

FIDELIS Industry Technical Terms of Delivery for Surgical Instruments and Medical Equipment

1. Purpose and Scope

2. Definitions and Abbreviations

3. General Requirements & Regulatory Compliance

3. General Requirements & Regulatory Compliance

4. Materials Specifications

5. Dimensions, Tolerances, and Metrology

6. Surface Finish and Cleanliness

7. Key Quality & Functional Criteria

8. Marking and Identification

9. Packaging and Delivery

10. Supplier Obligations & Quality Assurance

11. Documentation and Traceability

12. Confidentiality

13. Review and Amendments

14. Acceptance

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