A brief (but expert) guide to building a QMS for medical device startups

For medical device startups, implementing a Quality Management System (QMS) isn’t a one-time event - it’s an ongoing process that should align with the different phases of product development. Here's what every company embarking on their journey should know.

This blog will guide you through some of the major steps involved in developing a QMS. With expert video advice from medical device consultant Sam Shelley - we’ll show you some of the major pillars of quality management you need in place to take you through from concept to regulatory approval.

1: Get expert guidance early

Before building your QMS, seek advice from a regulatory or quality consultant. These experts can:

• Help you understand which ISO 13485 and regulatory requirements apply to your product.
• Identify which procedures you need first and how they should be structured.
• Ensure that your QMS can scale with your company’s size, experience, and culture.

Starting with expert guidance prevents costly mistakes and ensures that your procedures are practical, compliant, and scalable.

▶️  Watch: Medical device quality consultant Sam Shelley talk about what professional guidance start-ups should seek out:

2: Roll out procedures in line with product development

Many startups mistakenly believe they need a fully formed QMS from day one, but in reality, procedures can be rolled out in stages, ensuring that quality processes evolve alongside your product.

▶️  Watch: Medical Device Quality Consultant Sam Shelley talks through priorities for building quality procedures in your start-up:

Essential procedures to implement first:

As Sam Shelley explains, you don't need to do everything at once. But you do need a plan.  Here's her suggestions for critical procedures to agree and document early on:

• Design & development procedure – Defines how your product is designed, developed, and iterated.
• Document & record control – Ensures version control and traceability for all design documents.
• Risk management procedure – Helps identify, assess, and mitigate risks throughout the product lifecycle.
• Software development lifecycle (if applicable) – Ensures software is developed according to regulatory standards.
• User needs & requirements – Documents market needs and translates them into technical product specifications.

By implementing these early, your team will begin following procedures from the outset, you will have the building blocks in place for your Medical Device File—a key requirement for regulatory submission.

3: Define and link user & product requirements

A well-structured design process starts with user needs and translates them into product requirements.

🔹 User Requirement → What the market wants the product to achieve.
🔹 Product Requirement → The technical specifications needed to fulfil that need.

▶️  Watch: Medical Device Quality Consultant Sam Shelley breaks down how to translate user needs into product requirements:

By defining clear requirements early, you ensure that your verification process later in development proves your product meets specifications.

4: Verification and validation

Once your design is frozen, you must prove that your product meets both technical and user requirements.

✔ Product Verification → Confirms that product requirements are met through testing.
✔ Clinical Validation → Confirms that user needs are satisfied in real-world conditions.

Regulatory authorities require both before granting approval. If your documentation, testing, or validation is incomplete, approval delays or rejections can occur.

▶️  Watch: Medical Device Quality Consultant Sam Shelley explain the difference between verification and validation:

5: Regulatory submission & market launch

Once your QMS is established, design verified, and clinical validation completed, you can submit your Technical File to a Notified Body (for CE or CA markings) or apply for FDA clearance.

But after gaining approval, your QMS continues to ensure compliance as your product enters the market. Post-market surveillance, CAPA (Corrective & Preventive Actions), and continuous improvement processes become essential to maintain compliance.

At this stage, having a scalable eQMS continues to be critical. It ensures that as your product moves into real-world use and your operations grow, you can manage post-market feedback, document updates, and regulatory requirements efficiently and consistently. A scalable system supports traceability, speeds up audits, and allows your teams to stay aligned—without adding extra administrative burdens.

Key takeaways for Startups

✅  Seek expert advice early: A regulatory consultant helps you set up a QMS tailored to your business.

✅  Roll out procedures in stages: Align QMS implementation with product development phases.

✅  Define clear requirements: Start with user needs and translate them into product specifications.

✅  Prepare for verification & validation: Plan your regulatory submissions early to avoid delays.

✅  Build compliance into company culture: A QMS isn’t just about documentation; it’s about how your team operates daily.

Of course, in reality, there’s more to getting a medical device to market than this - and there will be set backs and bear traps along the way.

But by starting early and building a structured, ISO 13485-compliant QMS around your real workflows, you lay the foundation for success. The right systems and tools can help you capture the right records at the right time, streamline collaboration, and reduce the risk of costly redesigns or audit failures—ensuring your product is not only compliant, but safe, high-quality, and truly market-ready.