Sector
Instruments, implants, equipment housings, laboratory parts: what medical device manufacturers require of their suppliers, and how to prepare a suitable request for a quote.
The medical sector brings together very diverse device manufacturers: orthopaedic and dental implants, surgical instruments, imaging and diagnostic equipment, laboratory instruments, orthoses and prostheses. They all share one constraint: a device that touches a patient involves people’s safety, and regulation holds its manufacturer responsible for the whole chain, including the parts it subcontracts.
In practice, the manufacturer qualifies and monitors its suppliers. It often asks them for a management system compliant with ISO 13485, certified materials, validated processes, a defined cleanliness level and batch traceability. Parts are generally small, precise and produced in short to medium runs: micro-machining, bar turning, precision sheet metalwork, precision injection moulding.
The sector is not closed to young companies. Medtech start-ups, laboratories and design offices need prototypes and test parts well before the certification phase. The level of requirements can then be more flexible, provided it is agreed in writing.
Standards, regulations and practices that buyers expect from their subcontractors.
This quality management standard for medical devices covers regulatory compliance, risk management, documentation and supplier control. It is not always imposed on every subcontractor, but the manufacturer often requires it for critical parts.
Applicable since 2021, this regulation requires the manufacturer to have a quality management system, technical documentation and control of its suppliers. It provides for unique device identification (UDI): marking certain parts may be part of the order. Regulation (EU) 2017/746 covers in vitro diagnostics.
The ISO 10993 series governs the biological evaluation of a device in contact with the body. It applies to the finished product, not just the material. For implants, materials meet dedicated standards (ISO 5832, ASTM F136), with certificate and traceability.
Welding, passivation, cleaning, laser marking: a process whose result cannot be verified on every part must be validated (IQ, OQ, PQ qualification). Depending on use, manufacturing and packaging take place in a controlled environment (ISO 14644 for cleanrooms, ISO 11607 for packaging of sterilised devices).
Each batch is identified and linked to its material, its operations and its inspections. No change of material, process, machine or site may occur without the manufacturer’s prior agreement.
Each skill has its own detailed page: services, materials, price factors.
Micro-machining, precision turning and bar turning of parts in stainless steel, titanium or engineering polymers, with careful deburring and controlled surface finishes.
Passivation of stainless steel (for example to ASTM A967), electropolishing, anodising of titanium for colour coding: finishes that determine corrosion resistance and cleanliness.
Optical or tactile dimensional inspection of small parts, roughness measurement, reports and process validation: proof of conformity is part of the delivery.
Additive manufacturing of prototypes, surgical guides and custom parts; a part intended for a patient requires a validated process and a material qualified by the manufacturer.
Precision injection moulding, overmoulding and silicone for connectors, housings and single-use components, in a controlled environment if the specification requires it.
Boards, wiring and enclosures for electromedical equipment, whose design falls under the IEC 60601 series: the workshop manufactures to its customer’s file.
Under ISO 9001 as under ISO 13485, purchasing is not a trivial act: the manufacturer must evaluate, select and monitor its suppliers in proportion to the risk the part presents. A device cover does not call for the same level of control as an implant screw. The manufacturer therefore defines its criteria (certification, audit, quality history) and often formalises them in a quality agreement with the subcontractor.
This agreement sets out responsibilities: specifications, incoming inspection, nonconformance handling, change notification, record retention period and, sometimes, auditor access to the premises. A workshop wishing to position itself in the medical sector should prepare these elements: a presentation of its inspection equipment, nonconformance procedures, calibration tracking and batch records.
Not every workshop needs ISO 13485 certification: for non-critical parts, a manufacturer may settle for ISO 9001 supplemented by an audit. Our guide to certifications details what each standard covers.
The subcontractor’s role changes over the life of the device. In the design and prototyping phase, the priority is speed and precision: machining, 3D printing, cutting, with no particular regulatory requirement for parts that will not be used on a patient. In the verification and validation phase, parts must represent the future product: same material, same process, measurements and documentation. In the production phase, the manufacturer controls its supply chain: qualified suppliers, validated processes, change control.
CE marking of a device is the manufacturer’s responsibility under Regulation (EU) 2017/745, not the subcontractor’s. But the workshop contributes to compliance through the quality of its parts and records. For a start-up, the right strategy is often to work with a flexible workshop for prototypes, then to identify early the suppliers who can support series production. The guide from prototype to series describes this transition, and the one on drawing confidentiality helps you protect your developments.
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No text requires certification for every subcontractor. It is the device manufacturer, responsible for its supply chain, who sets its criteria. For a finished device or a critical part, ISO 13485 is frequently required; for a simple part, ISO 9001 and an audit may be enough. Ask your quality department before writing your project request.
ISO 9001 aims at customer satisfaction and continual improvement, in all sectors. ISO 13485 is dedicated to medical devices and aims at regulatory compliance: risk management, stricter documents and records, validation of special processes, traceability. A company certified to ISO 9001 is therefore not automatically compliant with ISO 13485.
No. ISO 10993 evaluates the finished device in its intended use. A material considered biocompatible can be altered by machining, a lubricant, inadequate cleaning or a surface treatment. The manufacturer judges this risk and defines what the workshop must comply with: permitted machining fluids, cleaning, packaging.
Yes, as long as the part is not intended for a patient. As soon as it enters a clinical trial or real use, the manufacturer must control its manufacturing and its suppliers. State the status of the part clearly in your project request and, from the first trials, prefer the series material and process.
ISO 9001, EN 9100, ISO 13485, IATF 16949: what they certify (a management system, not a product), how to check a certificate and in which cases to require them from a subcontractor.
EN designations, the role of molybdenum, chloride resistance, machining, welding and relative price: how to choose between stainless steel 304 (1.4301) and 316L (1.4404) according to the use of the part.
Typical content of a confidentiality agreement, trade secrets, ownership of drawings and tooling, scope of the 1975 French law and sharing habits: how to entrust your drawings with confidence.
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