Medical device design & development (D&D) processes have never been easy to establish. Organisations have been searching for ‘templates’ or ‘ideal’ procedures to manage multiple projects, hoping to achieve a consistent output. Till current, more than 50% of companies still uses general document software such as Microsoft Office or Google Docs stored on Dropbox or Google Drive to manage their medical device D&D. Such method is often insufficient to handle medical device development.
The good news is there are electronic quality management system (eQMS) software in the market specially designed for medical device companies. Such tools can help companies increase productivity, improve compliance, reduce documentation burden and get medical devices to market faster.
Here’s 5 reasons why eQMS can benefit medical device companies:
1. Automated, streamlined and standardised workflow
A preferred medical device eQMS platform generally has an interface that optimises and integrates design control, risk management and document management workflows together. They are usually developed based on ISO 13485, ISO 14971 and US FDA QSR requirements. The streamlined and standardised workflow is easily understood, allowing medical device D&D and risk management to be performed in an intuitive, yet compliant manner.
2. Increased accessibility and management oversight
An eQMS software that is cloud-based can be accessed from anywhere as long as there is internet connection. Processes such as document management, review and approval can all be done via the software. Such an eQMS platform typically allows multiple user-logins and the ability to manage projects through one portal. Companies with multi-site offices can now have teams collaborate and work through a single platform. Even external regulatory consultants and collaborators are able to access (when invited) the software and be involved in the project discussions remotely, saving up time and cost. Most importantly, the management can now have clear oversight on projects’ progress and deliverables.
3. Route and deliver files to key personnel with clear accountability
With automated routing and delivery of files to key personnel, eQMS allows the person to review and approve documents with ease and flexibility. Without the need of physically chasing people for approval, the requestor can now focus on his/her work that requires more attention. It also provides clear accountability - solving common issues such as lost of documents, signing off with wrong dates, missing information and etc.
4. Centralized system with close-loop quality management
eQMS can ease the administration burden with all the documents stored in a single centralised location. No longer do you have to worry about missing documents or incorrect versions updated. Any changes or revision to documents is immediately reflected on the system and everyone will be referring and working on the same data at any point of time. The ability to search for documents based on keywords via a centralised system also provide great convenience during an audit, compared to searching through hardcopy documents.
In paper-based approach, it is difficult to link documents/processes from one to the other, such as linking design control procedure to risk management. In an eQMS, key processes are usually linked together, which ensures traceability throughout the system. This provides audit trail and makes it easier to demonstrate evidence during audit.
Infographic: What you can benefit from adopting of an eQMS?
Changing from paper-based QMS to eQMS may sound daunting for some companies, as most believe that a considerable amount of time and effort needs to be invested. Some might even think they have to revamp their entire QMS to complement the eQMS platform. This is not true. With proper planning, the transition can be done within a short period of time and with minimal changes to your current procedures. We usually kick start the transition with a gap analysis first, before moving into the training and implementation phase! All in all, an eQMS is beneficial in the long run as it improves compliance, reduces cost, increases productivity, enhances traceability, reduces documentation burden and brings your medical devices to market faster!
Interested to setup and implement a QMS for your company? Contact us now for more information, including a 30-minute complementary demonstration on how an eQMS platform can help you achieve better compliance and get to market faster!