Manufacturing
Exposure
Manufactures of medical device and pharmaceuticals are expected to meet all regulatory requirements as set forth by the FDA. The guidance is intended to help manufactures implement quality systems and risk management approaches to ensure safety, efficacy, and complaince.
What Can Happen
If a manufacturer's product does not meet regulatory requirements, the result may be injuries and death related to unsafe products, time-consuming regulator agency reporting procedures, product recalls, litigation, and loss of revenue.
Top Recall Regulatory Violations
Design controls - receiving, in-process, and finished
820.30
703
1,759
36
Device acceptance
820.80
204
1,068
61
Production and process controls
820.70
119
830
58
Nonconforming product
820.90
17
415
28
Process validation
820.75
16
390
30
Purchasing controls
820.50
19
366
29
Device packaging
820.130
0
377
5
Device labeling
820.120
2
271
29
Personnel
820.25
0
159
2
Corrective and preventative action
820.100
0
122
7
How to Reduce Risk
Ensure the company has a comprehensive approach, with well-defined management responsibilities:
-
Quality Control Assurance
-
Quality reporting and management support
-
Formal and documented quality metrics
-
Compliance with industry standards (e.g. ISO, cGMP, UL, etc.)
-
cGMP compliance and facility sanitation controls
-
-
Sales and Marketing
-
Legal review of products, packaging, inserts, and advertising materials
-
Standard operating procedures to manage salespersons in a clinical environment
-
Annual training for regulatory, sales, and service/maintenance personnel
-
Standard operating procedures for managing and responding to off-label use
-
Formal and documented customer or end-user training
-
-
Post-Market Surveillance
-
Periodic review of FDA databases and industry new sources (e.g., TPLC, MedWatch, MedSun) for up-to-date information about similar products that have experienced adverse events, Medical Device Recalls (MDRs), and complaints
-
Compliance with FDA post-market surveillance requirements
-
Crisis management program
-
Product recall standard operating procedures
-
-
Complaint Handling
-
Formal Corrective An Preventative Action (CAPA) program
-
Protocols for receiving and recording complaints
-
Protocols for escalating complaints to senior management
-
Contact us to learn more about how we can help protect your organization.