Insight Technology -

medical devices

About

We off expertise in risk-based QA/RA compliance for medical device startups. Since 2008 we have contributed to successful QA/RA compliance and profitable acquisition of three medical device startups. Copying larger companies QMS systems is too costly for startups. Let us reduce your compliance efforts. Combining applied organizational, engineering and statistical skills, We • Partner with business sponsors to define success metrics and criteria • Build, lead, and coach project teams throughout project lifecycles • Charter, plan, resource, and schedule projects • Assess and resolve priorities and risks as they emerge • Continually update stakeholders on project status, cost, and risks • Deliver on time and within budget. Experience includes driving cross-functional communication, cost reduction, and quality improvement efforts in projects covering Product Design, NPI, Transfers, Supplier Management, Validation, and Remediation activities.

Technologies

Amazon AWS Google Analytics Nginx

Keywords

sterile disposables cardiovascular devices ai sterile disposable medical devices combination products qara samd electromechanical medical devices design & development risk mitigation safety assurance case infusion & flow control fda 510k clearance contract manufacturing product lifecycle management medical devices risk-based management sterile packaging medical equipment and supplies manufacturing qa/ra consulting product validation drug delivery systems fda compliant devices elastomeric infusion pump offshore manufacturing consulting healthcare equipment manufacturing medical device manufacturing class 8 cleanroom manufacturing patient safety enhancement

Location

28581 Springfield Dr, Laguna Niguel, California, United States, 92677

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