EUROPE TO INDIA

Knowledge, put into practice.

The programme carries design intent, process knowledge and hands on training into a controlled method in Gandhinagar.

European cardiac technology transferDesign · method · training

medical textile development bench with component geometry and sewing tools

THE CONTROLLED PACKET

Five records must describe one method.

A drawing identifies the component. A transferable capability also needs the work instruction, tooling approach, training evidence and agreed acceptance criteria.

CONTROLLED TRANSFER PACKETEUROPE TO GANDHINAGAR

Start with the component drawing, material specification and acceptance requirements. The work instruction, tooling and training method must be developed together.

Transfer is complete only when the method can be taught, checked and repeated against agreed evidence.

THE TRANSFER PATH

Carry the intent through every stage.

Design intent

Geometry, materials and acceptance requirements define what must be preserved.

Process knowledge

Preparation, tooling, sewing and inspection become one controlled method.

Training and qualification

Operators learn the method and demonstrate it against agreed evidence.

Pilot planning

Pilot lots and records give the device manufacturer a basis for assessment.

FROM KNOWLEDGE TO DAILY WORK

Build a method the local team can repeat.

Moving a process means understanding why each step matters, then making it workable at the new site. AJSM’s development focus is the local method: tools, instructions, training and checks built around the agreed component requirements.

Tools and fixturesDefine how to hold the supporting part, guide the textile and keep the work steady during sewing. A fixture is the tool that holds the part in a set position.
Work instructionsSet out material preparation, assembly order, stitch and seam requirements, and the points that need a check before the next step.
Training and practiceTeach the method on agreed samples and define what an operator must demonstrate before working on customer parts.
Inspection and handlingAgree the visual and dimensional checks, suitable magnification where needed, and how to protect and identify the component between steps.

The device manufacturer and AJSM must agree how process changes are reviewed and approved. A local improvement needs evidence that it still meets the component requirements.

PROGRAMME BOUNDARY

Assess the method before claiming completion.

Transfer status, pilot planning, customer assessment and qualification evidence must be agreed for the specific component.

AJSM does not present partner certification, regulatory approval or completed transfer as its own status.