Team Elexes 
CAPA | The Complete Guide to Corrective & Preventive Action for Medical Devices
Corrective and Preventive Action (CAPA) is an essential component of medical device companies that ensure the safety as well as effectiveness of your device.
These quality processes are essential for identifying and addressing nonconformities, defects, and process deviations in medical device manufacturing.
For start-ups and growing companies in the highly regulated medical device industry, implementing a robust CAPA process is crucial to enhancing product and process quality while meeting compliance requirements.
Our Expertise
Our experts will help you identify insufficiencies, determine inspection readiness, and evaluate risks, smoothing the inspection process and providing a greater chance of successful inspection. We will conduct periodic internal audits to ensure compliance with all the applicable ISO standards, cGMPs and internal regulations. Be it short targeted internal audits or more sustainable assessments across the quality management system (QMS), we have experts who can conduct a thorough audit and come up with any compliance gap that needs to be worked on.
Wish to know more about Premarket Approvals | PMA Basics, supplements, amendments, QMS & More…
Defining CAPA for Medical Devices
When it comes to medical devices, Corrective and Preventive Action (CAPA) is very critical as it focuses on helping medical device companies to identify, address, and prevent issues that could directly interfare with quality and compliance of your product.
The process usually includes systematic approach that help determine the root cause of non-conformity or defects and later implementing the required corrective actions to address these issues, avoiding any repetition.
A well-implemented CAPA system supports continuous improvement and ensures compliance with key regulatory standards, including FDA 21 CFR 820 and ISO 13485.
The CAPA process:
We help with:
⦿ Collecting and analyzing patient data.
⦿ Determining and identifying the root cause of non-conformity and defect.
⦿ Applying the CAPA actions.
⦿ Validating the effectiveness of the action taken.
By following these steps, medical device manufacturers can ensure the production of high-quality medical devices that meet regulatory compliance and foster confidence in their medical devices among patients.
Challenges associated with CAPA
Now that you have understood the importance and process of CAPA, it is time we get to the common challenges that medical device companies face while implementing an effective CAPA system.
However, many organizations encounter challenges with their CAPA systems. Some common issues include:
⦿ Limited cross-functional involvement
⦿ A reactive rather than proactive approach
⦿ Either excessive reliance on CAPA or insufficient use
⦿ Inadequate root cause analysis
⦿ Lack of a clearly defined CAPA process
It is very important to address these issues if you wish to build a robust and effective CAPA system that supports your organization’s goals and compliance needs.
8563 +
Saticfied Custimer
263 +
Experience Team
Our Services
Our Compliance Assessment Process
Our process begins with an in-depth consultation where we learn about your medical device, its intended use, and your specific goals. This helps us tailor our assessment to your unique needs.
Our team of experts is well-versed in global medical device regulations, including FDA submissions, CE marking, TGA requirement, Health Canada approvals, ISO, and more. We stay up-to-date with the latest changes in the regulatory landscape.
We will conduct a comprehensive review of your existing documentation, including design files, clinical data, quality management systems, and risk assessments.
Our consultants will perform a gap analysis to identify any areas where your device may fall short of compliance. This forms the basis for our recommendations.
Based on our findings, we will provide you with detailed recommendations and a roadmap for achieving compliance. This may involve revising documentation, conducting additional testing, or making necessary design changes.
Our services don't stop with just the assessment. We offer ongoing support to guide you through the compliance process, helping you address any challenges that may arise.
How can Elexes Help you with the CAPA Process?
Elexes offers comprehensive expertise in designing, implementing, and maintaining effective Corrective and Preventive Action (CAPA) systems tailored to your medical device needs. Our services ensure that your CAPA process not only meets regulatory requirements like FDA 21 CFR 820 and ISO 13485 but also enhances product and process quality.
Here's how we can assist:
Gap Analysis:
Elexes' experts will help you evaluate your CAPA system and determine the areas for improvement.
Documentation Support:
We understand the importance of proper documentation and, therefore, assist your team in maintaining accurate documentation.
Root Cause Analysis:
We also help you uncover the underlying causes for non-conformity by conducting a thorough investigation.
Effectiveness Verification:
We guide you in verifying the success of implemented actions by reevaluating the changes.
CAPA Implementation:
We also help you develop and implement corrective and preventive actions required on the basis of analysis performed.
Training and Awareness:
Our CAPA experts help train your team members with the required knowledge and expertise to sustain an efficient CAPA process for your company.
A Trusted Team of Consultants
Elexes offers a globally recognized ISO 13485 certification consultant who is renowned to enhancing your business credibility in the medical devices industry.
Local Language
Auditor
Our presence across the globe ensures audits are conducted by local-language auditors, facilitating clear communication and understanding.
Why Choose Elexes?
Expertise
Our experts provide guidance and consultants to help you adhere to necessary regulations, ensuring your products meet all legal requirements and is compliant to all necessary standards.
Local Regulatory Certification
At Elexes, we offer to assist in securing additional local certifications, enabling you to manufacture and sell medical devices in various markets across the globe.
Confidentiality
We offer complete confidentiality to all our clients which makes us one of the most trusted regulatory and quality compliance consulting.
Our New Product Approval Service Corner
We offer different services that will help you not only keep your product well in boundaries of regulations but also speed up the entire approval process. Some of these services are -
Associated Regulatory Authorities.
We’ve More
Than 256+ Global
Clients
The Best RA & QA Consultants
Clients Testimonials
Amazing Feedback Say About Services
Tom Birney
CEO Masterlink, Arizona
“
Elexes gave us immense support. Their Knowledge and thoroughness were excellent. I look for all of these qualities in consulting firms
“
Diane Bryant
CEO Novasignal, Los Angeles
“Prompt and competent! Elexes should be your next regulatory consultant. Their timeline-based project plan expedited the process.
“
Daniel Kinsey
President ViDava, Florida
“Professional and easy to work with! They expedited CE Marking for our products and also created clinical evaluations, risk assessments, and provided testing/manufacturing advice.
“
Linda Pan
Sr. Exe Treedental, Hong Kong
“Having Elexes as our import-export expert was a great choice. Elexes' team answered all our questions and guided us through every step.
“
Joshua Mink
Manager Outset Medical, California
“Highly recommend Elexes! They always meet commitments and follow through on action items.
“
Michal Depa
CTO Jana Care, Massachusetts
“Highly recommended! They excelled at regulatory projects, and document control, and grasped our product's nuances quickly.
“
Philip McFerran
MD Blackrock Pharma, England
“Kudos to the Elexes team! They're always proactive and have provided invaluable support to us with import, labels, and registrations.
“
Samip Shah
VP Regulatory AliveCor, California
“Excellent communication, diligent work. There is a strong quality background and QMS norms expertise.
“
Elizabeth W
Owner Liz Inc., Arizona
“Accurate and amazing! Their regulatory-compliant fact sheets for multiple products enabled us to sell domestically and internationally without issues. Their work had an impressive turnaround time.
“
Kurt Sysock
CEO Radformation, New York
“Elexes is a go-to for all FDA regulatory and quality systems work. They outperformed every expectation!
“
Popular Clients
We’ve 200+ Global Premium Clients
Looking For Regulatory Assistance?
Let's Talk How We Can Help You?
