5 Tips to Get ISO 13485 / ISO 14971 Certification

    Is your medical device company spending too much time trying to comply with regulatory requirements? If so, you're not alone; it's a problem that many organizations face.

    In the pursuit of regulatory compliance, Reva Medical incurred an exorbitant amount of debt as was quickly forced to file for bankruptcy. This delay allowed competitors to get to market first.

    Don't let regulatory compliance issues stifle the growth of your business.

    Here's how to get ISO 13485 / ISO 14971 Certification quickly and easily.

    ISO 13485 / ISO 14971: 5 Tips to Accelerate Certification

    Fortunately, there are quite a few things you can do to speed up the ISO 13485 / ISO 14971 Certification process. Let's briefly explore five of them.

    1. Pick the right eQMS for your company

    Your eQMS should help you secure and maintain FDA and ISO compliance. As such, it’s important to choose a company that can scale easily with you as you grow. The right eQMS will also be one that was built with your unique needs in mind.

    Qualio was created to be a perfect eQMS for medical device manufacturing companies. We designed our software so that startups and young companies can implement it and learn how to use it quickly.

    Additionally, our software provides all the necessary tools you need to track and record the development of your device from start to finish. Full lifecycle traceability like this is essential for compliance.

    2. Plan ahead

    Planning ahead is one of the most important things you can do for your company. There are many obstacles and potential pitfalls that could have disastrous results. Proper planning can help you avoid these challenges.

    Start by familiarizing yourself with ISO 13485 and ISO 14971 regulations. In this way, you will know exactly what is required of your company to maintain compliance and avoid facing some hefty fines. ISO 13485 defines what requirements medical device companies must adhere to with their QMS.

    The eQMS you choose to use should have:

    • A quality manual
    • Device master record (DMR)
    • Quality procedures
    • Work instructions
    • Forms
    • Specifications
    • Drawings
    • Quality records
    • Design history files (DHF)
    • Device history records (DHR)

    3. Lean on an expert

    You don't have to go it on your own. A consultant, such as Core Compliance, can review your processes, procedures, management systems, and other documentation to help you ensure compliance.

    They can also help you establish risk management files and processes and perform Gap Analysis. Core Compliance can help you:

    • Define the hazards
    • Establish intended use
    • Estimate risk
    • Establish framework
    • Develop a matrix chart
    • Run a risk management report
    • Implement risk control

    Find out more about the pros and cons of hiring a medical device consultant.

    4. Get Trained

    Oriel STAT offers a course you can take for ISO 14971 Medical Device Risk Management Training. Their course is recommended for design managers and engineers, quality assurance, manufacturing, research and development, service, and regulatory affairs professionals.

    Some of the learning objectives for this course include:

    • Describing the structure, purpose, and key concepts of ISO 14971 and ISO/TR 24971.
    • Learning the requirements for risk management planning, risk evaluations, risk analysis, risk control, risk management review and reporting, benefit-risk and residual risk analysis, and production activities.
    • How to apply risk management from the beginning to the end of the device’s development.
    • Learning how risk management integrates with your other processes, such as production and service controls, improvement, and feedback.

    5. Avoid these common problems

    Many medical device manufacturers expose themselves to weaknesses and vulnerabilities by not following ISO 14971 regulations.

    Some of the most common problems include ignoring EN ISO 14791:2012, treating design controls and risk management as separate processes, using FMEA for a risk management model, and not prioritizing risk management enough.

    Qualio can help you incorporate risk management into every step of every process intuitively. Our software makes compliance a breeze, with audit readiness for FDA 21 CFR Part 820, 21 CFR Part 11, ISO 13485, and ISO 14971.

    Find out more about how Qualio can help.

    How to Migrate From a Paper-Based System to eQMS

    Migrating from a paper-based system to eQMS doesn’t have to be a nightmare. We’ve helped hundreds of our customers make the transition a smooth one, and we can help you too.

    For example, Cardiaccs AS was struggling with a QMS that made it difficult to manage their processes and documents. Their current system was extremely complex and wasted their valuable resources and time.

    Even worse, it was non-compliant with FDA 21 CFR 82 and had major bugs and stability issues. Cardiaccs AS was able to implement Qualio within a few days, and they obtained ISO 13485 certification six months later.

    “Without Qualio, we couldn’t have achieved ISO 13485 certification before the end of 2015. Going through this certification process without ‘nonconformities’ is like passing a difficult exam and with the highest honors. I am so proud of the team, and this remarkable result.” — Cardiaccs AS

    Are you ready to ditch your outdated and inefficient paper-based systems and switch to Qualio? Download our free guide and learn How to Migrate From a Paper-Based System to eQMS.