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CONTRACT MANUFACTURING
Production management
We identify and engage with all the sub-contactor manufacturers needed to realise your product. This will typically include PCB assembly and plastics moulding companies, as well as a final assembly company. We endeavour to source all sub-contracting manufacturers in Australia where cost-effective.
Key services we offer in production management include:
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Sub-contractor service level agreements
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Development of custom manufacturing equipment
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Design and manufacture of text jigs
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Manufacturing process validation
Quality management
We establish all the quality management systems required by ISO 13485. Client can choose to run this system themselves, supported by Genesys, or (subject to negotiations) manufacture their product under Genesys' own quality management systems.
Key services we offer in quality management include:
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QMS systems establishment, including SOPs and quality manual
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Certification and re-certification
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Internal audits and certification by notified bodies
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Management reviews
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Corrective and preventive actions
Supply chain management
We identify and engage with all primary component suppliers. Some components will be supplied to manufacturing sub-contractors and in this case we ensure the follow service cascade down through their quality management systems.
Key services we offer in supply-chain management include:
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Component price negotiations
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Component, batch and product traceability
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Goods inwards inspection
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Manufacturing Process Control
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Quality audits of suppliers and continuous monitoring of performance
Customer Support
We provide after-market technical support to customers, relating to any trouble-shooting of the technology or systems designed and developed by Genesys. Subject-matter (medical) support is provided by you, the client of Genesys.
Depending on what level of QMS ownership the client takes, Genesys can offer other customer support services including:
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Customer feedback & complaints
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Adverse incident reporting to regulatory authorities
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Customer notifications
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Product recalls