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Medical Device CAPA (Corrective and Preventive Action) Process Consultants

CAPA impacts every aspect of your quality management system, from processes to products. Medical device companies with effective CAPA programs identify problems, investigate their root causes, document related incidents, and refine their processes to ensure that shortcomings do not happen again. They also enjoy an added benefit beyond problem solving and better audit findings: Their CAPA processes yield data that can be used to improve operations and financial performance.

Let us help assess and improve your current CAPA process and procedures

Oriel STAT A MATRIX consultants can conduct an independent review of your corrective and preventive action system that will uncover the areas in need of improvement. We can help you create and implement an action plan based on this assessment to ensure that your CAPA system is effective and efficient. We’ve been training and advising medical device companies on CAPA for decades, so we know how to apply best practices to your organization.

Ensuring you meet ISO and FDA CAPA quality requirements

Effective CAPA procedures can improve operational efficiency and product quality. As experienced medical device QA/RA consultants, we understand that maintaining regulatory compliance is also a key focus of CAPA. With this in mind, we can help you:

  • Comply with the FDA regulations (21 CFR Part 820.100) and ISO 13485 requirements (sections 8.5.2 and 8.5.3).
  • Reassure regulatory agencies that your company is capable of identifying and resolving issues.
  • Generate objective evidence for regulators that your organization has corrected problems.
  • Identify quality problems early in the cycle, before they lead to major nonconformities or an FDA 483 notice.
  • Bring you back into compliance if a regulator or Notified Body audit leads to major findings.

Our team can conduct CAPA investigations for you 

Many firms lack the time, resources, or internal skill sets to conduct effective CAPA investigations. Oriel STAT A MATRIX’s experts can plan and complete your CAPA investigations, so that your company obtains the results it needs to understand the root cause of a problem and take the needed corrective action. We will ensure that updated processes are validated and that all personnel impacted by those processes will be properly trained to maintain the improvements.

Contact us today to learn how we can help you improve your medical device CAPA process.

Select a course below to learn more or to register.
Course Name Public On-site
Updated!   Medical Device Vigilance Training:
Complaint Investigation and Reporting, Postmarket Surveillance, Recall Management
Optimizing CAPA Programs for the Medical Device Industry Training
Root Cause Analysis for Life Science Investigations Training

This course will give your organization the key tools for establishing a robust process for the initial intake and triage of customer complaints and any subsequent global regulatory reporting, whether an individual case (MDR, vigilance report) or a correction/removal to ensure product quality and/or safety. Click to learn more. 

Corrective and preventive action (CAPA) requirements in FDA-regulated environments can be confusing and difficult to implement.  Learn how to optimize your CAPA Progam to meet requirements and improve your business. Click to learn more.

This course will help you master the entire root cause analysis process, from accurately identifying the root cause of a problem to designing an effective intervention. This practical course goes beyond theory to teach you specific steps and tools so you can immediately apply what you learn. Click to learn more.

Provided below are a variety of practice related white papers, market updates and case studies.

Customized CAPA Training Addresses 483 Findings for a Medical Device Manufacturer

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