Set up your QMS painlessly

We help SaMD startups develop and implement a their ISO13485-compliant Quality Management System (QMS), so you can bring your software to market quickly and with less risk.

ISO 13485 Compliance

Common challenges for startups

Compliance with ISO 13485 for Software as a Medical Device (SaMD) is a complex, time-consuming process that can feel overwhelming, especially for startups. Many SaMD companies face the following challenges:

Limited Regulatory Know-How

Without a deep understanding of regulatory requirements, it's easy to miss crucial steps, leading to delays and increasing regulatory risks.

Overwhelming Complexity

Implementing a compliant QMS involves managing multiple processes and requirements. For startups, this can quickly become overwhelming, making it hard to stay on track.

Balancing Agile Practices with Compliance

Agile development thrives on flexibility, but regulatory processes demand structure. Finding the right balance is tough, and many startups struggle to keep both innovation and compliance moving forward.

High Stakes of Non-Compliance

Non-compliance can result in heavy fines, product recalls, or being denied access to key markets. The stakes are high, and startups can't afford to overlook regulatory details.

Constant Need for QMS Updates

A QMS isn't something you set and forget. It requires ongoing attention and updates to stay compliant, especially as your company grows and regulations evolve.

Misaligned or inefficient QMS

An off-the-shelf QMS that doesn't fit your needs will lead to inefficiencies and missed compliance targets. It could slow your team down more than helping them.

How we help

We provide expert guidance to help you set up a tailored QMS that seamlessly integrates with your existing business processes. Our proven approach minimizes risks and streamlines your compliance journey, accelerating your product's path to market with confidence.

1. Hands-on Support

We provide direct assistance at every stage, from navigating regulations to implementing best practices.

2. Tailored QMS Development

We help you get up and running with a QMS that fits your needs, integrates with your workflows, and scales with your growth.

3. Ongoing Maintenance

We offer continuous support to keep your QMS updated and effective as regulations and your company evolve.

Key Benefits

  • Accelerated time to market by avoiding regulatory delays.
  • Reduced risk of non-compliance and costly product rejections.
  • Custom-fit compliance strategies tailored to your business.
  • Scalable QMS to grow with your business.
  • Long-term cost savings through proactive compliance management.

How we work

We offer three tailored packages to accelerate your path to regulatory compliance. Choose the option that best fits your SaMD startup's needs and take the first step towards seamless compliance today.

Ongoing Support

  • We offer assistance with your QMS, whatever stage you are at.
  • Gap Analysis
  • QMS Improvement Plan
  • Implementation Follow-up
  • Continuous Support
Get Started

Full Package

  • We help you kickstart your path to regulatory compliance.
  • Initial Consultation
  • Gap Analysis
  • QMS Improvement Plan
  • Implementation Follow-up
  • Continuous Support
Get Started

Customized Support

  • Have something else in mind?
  • Let us know how we can help.
Contact us
What our services include:
  • Initial Consultation:

    A comprehensive discussion to understand your specific needs, goals, and current QMS status.

  • Gap Analysis:

    A thorough assessment of your existing processes against regulatory requirements to identify areas for improvement.

  • QMS Improvement Plan:

    A tailored strategy outlining steps to enhance your QMS and achieve compliance.

  • Implementation Follow-up:

    Ongoing support and guidance as you implement the improvement plan, ensuring you stay on track.

  • Continuous Support:

    Ongoing support with regular check-ins to address challenges and maintain compliance as you grow. We offer flexible, expert guidance tailored to your evolving needs.

Frequently Asked Questions (FAQ)

We specialize in helping SaMD startups comply with key regulations and standards, including:

  • MDR (Medical Device Regulation): The European Union's MDR governs the safety and performance of medical devices, including SaMD. We assist you in navigating its requirements to ensure smooth market entry in the EU.
  • FDA: For U.S. market entry, we guide you through the FDA's regulatory requirements, including compliance with 21 CFR Part 820 (Quality System Regulation) and submitting premarket notifications (510(k)) or premarket approvals (PMA).
  • Related ISO Standards: We help you meet critical international standards, such as ISO 13485 (Quality Management Systems for medical devices), IEC 62304 (Software life cycle processes), and ISO 14971 (Risk management).
  • Data Privacy Laws: For data privacy laws, see the Data Strategy section, where we cover compliance with laws like GDPR, HIPAA, and CPRA for handling sensitive healthcare data.

We advocate for an approach based on AAMI TIR45:2023, which is a standard that reconciles the needs for regulatory compliance with agile software development lifecycle processes.

After your QMS is fully implemented, we continue to support your compliance journey with up to 300 minutes (5 hours), per package. You can use these hours to discuss any questions or doubts you have about the QMS, and we will help you with them. More hours can be purchased at a standard rate.

The timeline for setting up a fully functional QMS depends on your company's current processes and regulatory needs. On average, it takes 3 to 6 months to design, implement, and fully integrate a compliant QMS.