November 15, 2023/
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Support development teams to meet cyber security regulation requirements (USFDA, EUMDR etc)
Support development teams to meet cyber security regulation requirements (USFDA, EUMDR etc)
Provide offshoring services (from team in India) on Complaint handling, remote support on Quality system, CAPA etc. to take cost advantage.
Provide trainings on QMS Awareness, Internal audit, CAPA, Problem solving tools and techniques, Advance Product Quality Planning (APQP) topics – FMEA, Gage R&R, Statistical Process controls – Cpk & Ppk…
Manage Complaint Handling unit by providing optimized cost services (Hybrid team working from India)
Support Life cycle management of existing products by providing support on handling customer complaints, R&D support, supplier quality etc.
Provide support in supplier development / supplier qualification / handling supplier quality issues.
Provide services to transition quality systems and products to meet new EU MDR regulation requirements (including Pre-evaluation of Tech files).
Provide services to cater to your needs for Global regulations requirements like USFDA QSR, ISO13485, ANVISA (Brazil), JPAL(Japan) etc.
Diagnose health of quality function and provide guidance to create program towards high customer satisfaction and low cost of non-quality. Support on running cost of non-quality program
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