Choosing an eQMS for a MedTech startup is not straightforward. When a startup develops a medical device, it must establish a quality management system early enough to control its design, risk management and regulatory compliance activities.
For a small team, the choice often appears to be limited to two options:
- building a manual QMS using Word documents, Excel spreadsheets and shared folders;
- investing in a specialised eQMS that may be complex and expensive.
Both approaches can be appropriate in certain situations. However, each presents significant limitations for a MedTech company that is still developing its product and organisation.
There is a third option: establishing a structured QMS within a collaborative environment that the team may already know and use, such as Confluence.
Why Do Startups Often Begin with a Manual QMS?
A company with five or ten employees generally does not need the same tools as an international manufacturer operating multiple sites with hundreds of users.
Using Word documents, Excel spreadsheets and a shared folder structure may therefore appear logical. This solution is accessible, flexible and inexpensive. It also allows the team to learn about its own processes progressively.
However, a manual QMS remains simple only if its structure has been properly defined from the beginning.
As the project progresses, the company must manage activities such as:
- document versions and approvals;
- responsibilities and training;
- user and product requirements;
- design and development activities;
- risks and risk control measures;
- verification and validation;
- suppliers and subcontractors;
- product and QMS changes;
- nonconformities and CAPAs;
- audits and management reviews;
- post-market surveillance activities.
Difficulties arise when this information is distributed across different documents, spreadsheets, folders and email communications.
The information may exist, but the links between the different elements become increasingly difficult to establish, demonstrate and maintain.
The Main Risk: Having to Reconstruct Traceability
For a medical-device manufacturer, the challenge is not limited to document storage.
The company must be able to demonstrate consistency and traceability between elements such as:
- user needs;
- design inputs;
- identified risks;
- risk control measures;
- technical specifications and design outputs;
- verification and validation activities;
- product changes;
- decisions made throughout the development process.
In a system based entirely on independent documents and spreadsheets, this traceability depends heavily on the discipline of the team.
Such a system may work during the earliest development stages, but it can become more difficult to maintain as the number of documents, versions, users and modifications increases.
Waiting until the manual QMS becomes unmanageable before changing systems can create an additional problem. The migration often occurs when the company is preparing a regulatory submission, ISO 13485 certification, an audit or a funding round.
The team must then transfer documents, verify their status and versions, retrieve evidence of approvals and sometimes reconstruct part of the product’s development history.
Is a Specialised eQMS Always the Best Solution?
A specialised eQMS can provide significant benefits, including:
- automated workflows;
- version control;
- electronic signatures and approvals;
- training management;
- CAPA and nonconformity tracking;
- dashboards and quality indicators;
- audit trails;
- centralised management of records.
For a mature company or a complex organisation, these capabilities may justify the investment.
For a startup, the situation may be different. Some eQMS platforms were designed for larger organisations and may involve:
- substantial subscription fees;
- costs calculated per user;
- implementation and validation costs;
- platform-specific training;
- workflows that are more complex than the company requires;
- dependency on a particular supplier;
- the need to maintain the eQMS alongside other tools already used by the team.
A small company may consequently find itself adapting its organisation to the software, whereas the system should primarily support the company’s actual activities and processes.
How to Choose an eQMS for a MedTech Startup
Between a fully manual QMS and an enterprise eQMS, a third approach consists of using an existing collaborative platform to structure the company’s quality processes.
Confluence is particularly relevant for teams that already use it for technical documentation, project management or software development.
A QMS established in Confluence can bring together:
- procedures and work instructions;
- forms and quality records;
- roles and responsibilities;
- design and development documentation;
- risk-management files;
- verification and validation plans and reports;
- CAPAs and change controls;
- supplier documentation;
- audit records;
- post-market surveillance activities.
Complementary applications can also be used to organise review, approval and signature workflows according to the company’s requirements.
This approach allows the organisation to remain in a familiar environment while providing more structure, collaboration and traceability than a collection of independent files.
“Starting Simple” Does Not Mean Starting Without Structure
A startup does not need to automate every quality process from its first day of operation.
However, it should establish the processes governing its critical activities early enough. For a device that is already under development, these processes generally include:
- control of documents and records;
- design and development;
- risk management;
- supplier control;
- competence and training;
- change management;
- nonconformities and corrective actions;
- preparation for regulatory and post-market activities.
The QMS should remain proportionate to the size of the organisation, the nature and risk class of the device, and its stage of development.
The system can then evolve progressively as the company grows.
The objective is not to reproduce the QMS of a large manufacturer from day one. It is to establish a sufficiently robust structure to preserve the project’s history, justifications and traceability.
ReadySet for Confluence: A Structured Foundation for MedTech Teams
ReadySet for Confluence was developed for startups and small MedTech companies that want to avoid both:
- the workload involved in authoring a complete QMS from scratch;
- the complexity and cost of an enterprise eQMS.
ReadySet provides a quality management system structure that can be implemented directly in Confluence. It includes an organised set of procedures, forms and reference documents covering the principal processes of a medical-device manufacturer.
Dedicated versions are available for medical devices, in vitro diagnostic medical devices and medical device software.
ReadySet provides a starting framework. It is not an automatically compliant QMS or a system that is ready for certification without implementation by the company.
Each manufacturer remains responsible for:
- adapting the procedures to its organisation;
- defining roles and responsibilities;
- determining the applicable regulatory requirements;
- documenting its own activities;
- training the relevant users;
- implementing and maintaining the system;
- validating computerised tools when required.
This distinction is essential: ReadySet provides the structure, but the manufacturer builds, implements and controls its own QMS.
Questions to Ask Before Selecting an Approach
Before choosing between a manual QMS, a specialised eQMS or a QMS integrated into a collaborative platform, the company should consider the following questions:
- Is the medical device already under development?
- How many people will create, review or approve documents?
- Does the team already use Confluence or a comparable platform?
- How will traceability between requirements, risks, design outputs and verification be maintained?
- Is ISO 13485 certification or a regulatory submission planned?
- Can the system evolve without requiring a major migration?
- Are the costs and functionalities proportionate to the company’s current needs?
- Who will be responsible for implementing and maintaining the QMS?
The best solution is not necessarily the one offering the greatest number of functions. It is the one that enables the company to control its processes, documents and records effectively while supporting its future development.
Conclusion
A MedTech startup does not necessarily have to choose between an improvised manual QMS and an enterprise eQMS.
A QMS structured within a collaborative environment such as Confluence can provide an intermediate solution: more organised and traceable than a collection of independent files, but more flexible and proportionate than an enterprise platform.
The essential point is to establish the right structure at the right time.
The earlier this structure is implemented, the lower the risk that the company will have to reconstruct its development history when preparing for certification, an audit or a regulatory submission.
Would you like to discover how ReadySet can be adapted to your organisation and medical device?
Contact AZ Biotech Consulting for further information or to arrange a presentation of ReadySet for Confluence.