Goal
To determine the gaps in documentation between the existing CE Technical File (and other historical design documents) and the requirements of a design history file (DHF)
Background
A global premier health care company provides products and services for renal dialysis has designed and manufacturers a therapy system for continuous renal replacement therapy (CRRT), intended for the treatment of acute kidney failure in critically ill patients at intensive care units. The system is CE Marked and distributed in Europe. The health care company intends to obtain FDA 510(k) clearance.
Objectives
- Assess current status of design control documentation
- Conduct gap assessment between US and German facilities
- Provide recommendations to address gaps
Regulatory Need
- DHF compliance to 21 CFR 820.30
- 510(k) clearance for the renal dialysis
Activities
- Review and audit over 100 design documentation; hardware, software, risk management and labeling claims
- Work with cross-functional and cross-cultural teams to accomplish goals per proposal
- Identify and prioritize over 35 major gaps to address prior to 510(k) submission
Outcome
- Completed assessment with identified gaps
- Provided recommendations to close the gaps
- Enabled health care company to move forward with the plan to submit a 510(k) for the renal dialysis medical device in a timely manner
About MAE Group
MAE Group is a business service provider specializing in domestic and international Regulatory Affairs, Clinical Affairs, Quality Systems, Cybersecurity and Networked Security services to healthcare companies to commercialize medical and in vitro diagnostic devices in target markets.
