Discuss a component FREQUENTLY ASKED QUESTIONS
Practical questions from device manufacturers and their engineering, quality and supply teams.
AJSM focuses on hand-sewn textile components for heart valve devices. Its two main component families are mechanical valve sewing cuffs and annuloplasty ring coverings. AJSM can also review other sewn medical textile components against a drawing and agreed requirements.
Explore the two component familiesA sewing cuff provides a textile margin around the support of a replacement valve. A ring covering follows the shaped support of an annuloplasty ring used in valve repair. They have different shapes, coverage and seam requirements.
Compare cuffs and ring coveringsThis website describes component manufacturing for medical device companies. It is not a patient ordering service or a source of treatment advice. A textile component is one part of a complete device.
Contact AJSM about component supplyAJSM’s operational facility is in Gandhinagar Special Economic Zone, Gujarat, India. The registered office is in Mumbai. Contact AJSM to discuss a facility visit or the requirements for a supplier assessment.
See the facility informationAJSM describes its quality management approach as aligned to ISO 13485. This website does not claim ISO 13485 certification. For a supplier assessment, ask AJSM for the current quality documents and evidence relevant to your programme.
Read the quality approachIt refers to the controlled assembly environment at the Gandhinagar facility. A cleanroom classification is separate from quality management certification and finished-device approval. Your team should agree the environment and process evidence needed for its component.
Review the assembly environmentThe training approach covers cleanroom conduct, material handling, component preparation, sewing, inspection and records. Operators are qualified for the defined work before working on customer parts.
Read about people and trainingThe programme concerns design information, process knowledge, training and the evidence needed to establish defined component work in Gandhinagar. Transfer status, pilot planning and qualification evidence must be reviewed for the specific programme.
See the transfer approachStart with the component and device application, your current drawing or process stage, expected volume, target timing and intended markets. If some details are not yet known, say so. Keep the first message non-confidential until you have agreed how to share technical files.
Prepare a component briefYes. Ask about a confidentiality agreement in your first message. Agree the terms and file-sharing method before sending confidential drawings or process documents. Do not send patient records.
Contact AJSM directlyThere is no single figure on this website. These depend on the component, process stage, material requirements, qualification work and volume. Share the information available so AJSM can review the scope before discussing a quotation or schedule.
Explain your requirementsNo. The brief builder prepares an email on your device. Nothing is uploaded through the form. You review and send the message using your own email application. You can also email AJSM directly.
Read how enquiry information is handledNeed an answer about a particular component? Contact AJSM with the drawing stage and the question your team needs to resolve.