
ISO 13485:2016 lays down the requirements of a Quality Management System for medical devices. Now, compliance with a QMS requires A LOT of documentation. And, A LOT of documentation often leads to A LOT of problems.
A sophisticated electronic QMS/DMS is not only a solution to these problems, but also helps you to implement the PDCA cycle that protects the integrity of your quality processes and documentation, with ease.

Disadvantages of Manual DMS
- Risk of misplacing or damage
- Security issues
- Physical clutter
- High costs
- Lack of storage space
- Difficulty in search, distribution, tracking and retrieval
Meddevices Lifesciences provides you with a platform for E-QMS/DMS to ensure that your organization as well as your products meet with the regulatory compliance standards set in ISO 13485:2016, ISO 14971:2019 and more.
Our E-QMS/DMS platform helps you to easily integrate your design control, regulatory compliance and quality management in a single system.

Our E-DMS includes modules for:
- Document Control: The basic requirement of ISO 13485 is that the manufacturer keeps and maintains appropriate and adequate documentation and records that gives a clear picture and strengthens the process of quality assurance and auditing. Our E-DMS helps the user to organize, review, control and audit all documentation of the product. It also helps you to keep track of any changes made to a document.
- Risk Management: Our E-DMS helps medical device manufacturers in constant assessment of any potential risks and its effects on the customers, workers and processes. Regulatory Bodies ask for a risk assessment of the probable effects of the manufacturer’s products.
- Training Management: The training module of our E-DMS helps manufacturers to plan training activities in their organization and track the performance of the employees and workers by conducting follow-up exams and managing and comparing the results.
- Non-Conformities: When your product deviates from the regulatory requirements and specifications, it is prudent to resolve the non-conformity ASAP. Our E-DMS allows the manufacturer to record and keep track of the deviation from the moment they are identified until the matter is resolved.
- Complaints Management: With the help of our E-DMS, tackle all the challenges of your medical device and back-up your compliance with ISO 13485 especially in the are of handling complaints. Keep up-to-date with the status of the customer complaints received, essential corrective actions taken and the result of that corrective action.
- Audit Management: This module of helps you to prepare and manage your audits electronically. Periodic audits are crucial to ensure product safety and quality, and compliance with the regulations. The manufacturer will have the facility to specify an audit checklist outlining the subjects of audit and can then link these to the audit finidngs.