QMS Jumpstart

Your all-in-one Quality Management System platform.

A high-quality QMS helps manufacturers and developers create better medical devices and better businesses, driving patient care forward. We believe that setting up a compliant QMS shouldn’t be complicated, overly time-consuming or break the bank.

That’s why we’ve created QMS Jumpstart, a platform specifically geared towards those that are looking for a helping hand without outsourcing the whole process.

What is a QMS?

A Quality Management System (QMS) is defined as “a formalised system that documents processes, procedures, and responsibilities for achieving quality policies and objectives. It helps organisations consistently meet customer and regulatory requirements."

A QMS is like the backbone of your business. It's a set of guidelines and processes that ensure your products consistently meet customer and regulatory requirements throughout their entire lifecycle. Think of it as having a clear roadmap for quality, safety, and continuous improvement.

There are several interlinking components to a robust QMS, all of which require development, implementation, improvement and maintenance.

  1. Phase 1: Foundation

    • Leadership & Governance
    • Management Review
    • Quality Planning
    • Audit Readiness & Reviews
    • Infrastructure
    • Team Competency & Training
    • Work Environments
    • Resource Mapping
    • Change Management
    • Change Impact Assessment
    • Master Record Management
    • Version Control

  2. Phase 2: Innovation

    • Product Innovation Lifecycle
    • Risk Management
    • Design Input-to-Output Traceability
    • Verification & Validation (V&V)
    • Risk Management
    • Mitigation Strategy
    • Lifecycle Risk Monitoring
    • Patient Safety Analysis

  3. Phase 3: Operations

    • Operations & Scale
    • Manufacturing Process Controls
    • Identification & Part Traceability
    • Supplier Management

  4. Phase 4: Device Improvement

    • Market Intelligence & Safety
    • Post-Market Surveillance (PMS)
    • Vigilance & Reporting
    • Clinical Feedback
    • Corrective and Preventive Action
    • Root Cause Analysis
    • Continuous Quality Growth
    • Prevent/Eliminate Nonconformities

With a well-structured QMS, you are well on your way to consistently producing safe, effective medical devices.

What is ISO 13485?

ISO 13485 is the most widely used international standard for Quality Management Systems in the medical device industry. It sets out the requirements for a QMS for medical device manufacturers and developers, ensuring that all organisations involved in the design, production, installation and servicing of medical devices adhere to quality management principles. Compliance with ISO 13485 ensures manufacturers produce products that consistently meet regulatory and customer requirements, and demonstrates a commitment to producing effective, safe medical devices.

How does QMS Jumpstart work?

QMS Jumpstart is designed with startups and small medical device and IVD device developers in mind. It’s designed to grow with you, ensuring you meet ISO 13485 requirements now whilst protecting your business in the long term.

The platform lays out a clear structure for your QMS, ensuring clarity and making the complex simple. QMS Jumpstart provides you with a thorough template for each of the documents required in your QMS, easy-to-follow SOPs and detailed training materials to help you understand each clause, the information that needs to be in each document, and how to ensure the different parts of your QMS fit together harmoniously.

With QMS Jumpstart, you’re not out on your own. Our regulatory experts are on hand to help set you up and get you on your way.

How do I get started?

To find out more about QMS Jumpstart, or get started on your QMS, talk to a member of our regulatory team using the booking form below.

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