Negative Pressure Wound Therapy
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![Renasys Touch]()
Renasys Touch
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![Renasys EZ PLUS]()
Renasys EZ PLUS
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![Renasys GO]()
Renasys GO
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![Portable NPWT]()
Portable NPWT
Services Provided
Program / Project Management
Risk Management
Systems Engineering
Usability Engineering
Software Quality
Electrical Product Safety
Client Background:
This client, a UK-Based multinational giant, required our help to replace products impacted by planned obsolescence.
They hoped to build upon the product’s features in a customer-valued manner while maintaining compliance with several electrical standards (IEC60601-1 3rd Ed) while achieving compliance with new standards (IEC60601-1-11; Home-Use Devices).
The product is in routine use in hospitals but also travels between the patient’s home and outpatient facilities, as the patient recuperates over weeks or months.
Client’s Request(s):
The client requested that we link newly acquired products into the portfolio, and revise existing products to make them home-use compliant. Additionally, we were asked to:
Provide corrective actions to recent 483s and Warning Letters
Assist in usability testing to support products’ and accessories’ release
Support Risk Management and Software Compliance from development to product launch.
Project Actions:
In addition to the services listed above, we also provided root cause analysis, problem-solving, and activities related to return-to-market for the previously-withdrawn products (due to FDA Warning Letter).
Outcome:
The efforts concluded in the successful return of the product to the market by addressing the issues enumerated within the FDA’s letter.
Also, we achieved compliance with the following standards:
IEC 60601-1
IEC 60601-1-2
IEC 60601-1-8
IEC 60601-1-11
IEC 62304
IEC 62366
ISO 14971
Finally, our staff assisted onsite and in teleconferences with the FDA to achieve a successful 510(k) clearance.