What’s the plan? A seamless product realisation process for ISO 13485

So, you’ve had your brilliant idea. You know what kind of medical device you want to build. You have a vision of the product and your team are behind you. But do you have a plan for product realisation?

What is product realisation?

Having a planned product realisation process in place is a formal requirement of ISO 13485:2016. Clause 7 defines all the resources, processes and controls you need in place to correctly identify customer needs, transform them into a set of verified designs, produce a medical device that is validated against documented requirements - then produce it at scale to the required standards.

Why do you need a plan?

How many product development processes have you been involved with that have lost focus along the way? Have many teams have you seen collapsing into competing silos and disappearing down development rabbit holes?

A product realisation plan is a blue print for complete project control that can avert these disasters. It is a clear, documented approach which will help you navigate all the design, development and regulatory challenges that lie ahead. It will help you focus on required objectives and meet required quality standards in everything you do. It will ensure you have complete traceability throughout your product development process.

Done right, it won’t just help you meet the regulation. It will help you overcome some of the most serious commercial challenges that can plague medical device development. The right planning process will help prevent costly mistakes, including over-delivery and over-processing within your project, keeping your team laser-focused on meeting documented customer needs even across long and complex design cycles.

What should be in the plan?

ISO 13485; 2016 Clause 7.1, specifies what’s required in your initial planning process to ensure you have exactly the right resources and quality systems in place to deliver your end product, while continually mitigating the risk of product failure and harm to end users.

ISO 13485 7.1 requires you to:

• Establish and document the quality requirements for your product(s).
• Document processes for risk management
• Define your required processes and define the supporting documentation you will need to implement them
• Outline the company and team resources/structure that you will need
• Define employee qualification and training requirements.
• Establish your processes for verification & validation, measurement, monitoring, handling, inspection, storage, distribution, and traceability.

What other planning requirements are there in Clause 7?

Clause 7 of ISO 13485’s product realisation section doesn’t stop there. It specifies the planning and documentation requirements for other critical steps of your process, too:

7.2 Customer-related processes

7.2 demands you gather and document detailed customer requirements before you begin development so that you know exactly what your device needs to do in every use case. These include:

1. requirements specified by the customer, including the requirements for delivery and post-delivery activities;
2. requirements not stated by the customer but necessary for specified or intended use, as known;
3. applicable regulatory requirements related to the product;
4. any user training needed to ensure specified performance and safe use of the medical device;
5. any additional requirements determined by the organisation.

The standard demands you to have planned review and acceptance procedures for these requirements before you start using them in your formal design process.

7.3 Design and Development

Your organisation is also required to plan and control all aspects of your design and development process, creating a clear method through which requirements are turned into specifications, then into designs and products that are continually validated against deliverables.

Follow this link to read more about digitising a robust and flexible phase-gated design process that exactly meets the regulation.

7.4 Purchasing

When purchasing products, organisations need to verify that their suppliers are able to provide products to meet the needs of the organisation, and comply with required quality standards. You need to have plans in place to regularly assess and monitor their compliance with quality standards.

Organisations need to keep detailed information on the products they purchase, and verification of anything they purchased, and when they received the material.

7.5 Production and Service Provision

13485:2016 says you must have plans and processes in place to control critical factors in product realisation, including:

• Production and service provision
• The cleanliness of all products
• Installation activities
• Servicing activities
• Specific requirements for sterile devices
• Verifying processes for production and service provision
• Appropriate requirements for verification of processes for sterilisation and sterile barrier systems
• Identification
• Traceability
• Customer property
• Preservation of product

7.6 Control of monitoring and measuring equipment

The organisation is also required to not only monitor and measure their products, but determine the appropriate equipment that they need to adequately and accurately monitor and measure. As an organisation you need to plan for your equipment to be maintained and calibrated correctly.

What’s the point of product realisation planning?

Planning the way you will deliver your product against customer and quality requirements is a key part of ISO 13485:2016. It is also the key to the good governance that can help bring you commercial success:

• The plan defines the processes and controls you need in place for risk management. 
• It prepares you for audit by ensuring complete traceability across your design, development and delivery cycle.
• The plan will form the basis of a shared understanding amongst project stakeholders about exactly what is required of them, keeping everyone focused on delivering on defined goals
• Effective planning can stop your team disappearing down development rabbit holes - guarding against over-processing through formal checks and acceptance procedures.
• Done right it can also be a useful tool to help you convince investors that you are capable of building a device that exactly meets the needs of the market within a required time frame.

Choosing the right digital tools to ‘bring your plan to life’ 

But to define and implement this plan effectively, you will need the right digital tools.

These are the tools that can help turn your plan from a set of 2-dimensional paper documents, into a living, breathing Quality Management System that will be your framework for flexible, automated and compliant development process.

Choose an electronic quality management system (eQMS) which can help you:

• Define and stage gate every required phase of your development process from initial requirement gathering, to design iteration and release to manufacture
• Create templates of required documentation for each stage of your process that your team can complete and approve before triggering the next stage of development
• Control document workflows and automate required processes
• Help you set up and then complete verification and validation processes for your device, documenting evidence for audit as you do so
• Configure your quality system to match the way your organisation works. Ensure you are not spending weeks and months trying to meet the demands of an inflexible eQMS.
• Demonstrate to regulators that you have planned and documented your processes in a way ‘that is suitable for [your] organisation’s method of operations’, as stated in ISO 13485

Plan first – execute second

Like so many developers before you, it’s always tempting to get ‘stuck’ in and start designing and building prototypes as soon you’ve had your brilliant idea. But resist that temptation!

Effective product realisation planning is how you will mitigate the possibility of making mistakes and omissions in design and development process that can lead to product and commercial failure.

Attempting to plan and document your medical device project using only paper, word documents or excel sheets is a recipe for organisational chaos. Instead, choose the tools that can help you digitise your plan helping you define, implement and automate the processes that will ‘bring them to life’. Choose the digital tools that will help you create a bullet-proof framework for regulatory compliance, while helping you deliver the right product to market as quickly and efficiently as possible.