Quality Management System

Develop or refine a Quality Management System to enhance organizational performance and establish a strong foundation for sustainable development

QMS Services

Manufacturers of medical devices are required to establish, document, implement, maintain and continuously improve the quality management system (QMS). The QMS shall be in compliance with national regulations of the countries where manufacturers are intended to distribute their medical devices. It shall be set up in the most efficient manner proportioned to the risk class and the type of devices. The QMS shall cover all parts and elements of the manufacturers’ organisation dealing with the quality of processes, procedures and devices. The QMS might also be required for suppliers or external parties that provide products including quality management system-related services to medical device organisations.

We support you with the following quality services:

establish and update the QMS according to ISO 13485;
remediate the QMS to meet ISO 13485 and the national requirements;
set up a risk management system in accordance with ISO 14971
prepare the QMS to stand medical device single audit program (MDSAP);
routine quality management service e.g. writing quality procedures, auditing and providing consultancy for significant deviation events that may impact the compliance status and avoid significant business risk

Case Study 1: MDSAP Certification

Our client is a world leading health care provider based in Central Europe with multiple production sites in Europe and Asia and sells medical devices to over 100 countries in the world. The client has approached us for a MDSAP (Medical Device Single Audit Program) project. MDSAP is a program that allows medical device manufacturers to be audited once for compliance with the standards and regulatory requirements of up to five different medical device markets, namely Australia, Brazil, Canada, Japan and the United States.

In the pilot phase of the MDSAP project, Health Canada transposed the MDSAP into the Canadian Medical Device Regulation, which requires all manufacturers planning to market their devices in Canada to be certified to MDSAP. Canada has been an important market and will remain essential for our client. Therefore, obtaining MDSAP certification in a timely manner was a top priority for us.

We started the project with:

Conducting a quality management audit to analyse the current status of client’s QMS and identify deviations from the MDSAP requirements.
Establishing a project plan and defining the MDSAP Task Force with the involvement of the client’s stakeholders for the actions to be taken.
Since our client did not expect to do business in Japan in the next two years, we advised the client to exclude Japan from the initial MDSAP certification in order to effectively use the limited resource and save costs. Japan could be added to the MDSAP certificate during the next MDSAP audit.
The training of the core team on the MDSAP Companion Document.
Aligning all MDSAP tasks with the client’s existing QMS process documents, creating a list of process documents to be revised or generated and defining a timeline with the responsible parties and for each action.
The outcome of the internal audit was explained to each stakeholder and a realistic solution and timeline for implementation was developed.
For stakeholders who did not have the necessary resource, we completed the process documents and provided them with appropriate training.
Prior to the scheduled MDSAP audit by the Notified Body, all required process documents were stored centrally in the client’s e-platform, which all stakeholders had access to throughout the audit.

The entire implementation phase took about 8 months until the new certificate was granted. After MDSAP certification, the client is able to continue selling its medical devices in the relevant markets. The client’s inspection cost was reduced by 75% because the relevant authorities carried out less frequent inspections.

Case Study 2: cGMP Certification

Our client is a leading global healthcare solutions provider based in Central Europe. In order to boost Chinese business by participating in local tenders as a domestic medical device manufacturer, the client has decided to establish a new production site in the country to qualify as a domestic manufacturer.

The client expected to receive its Chinese provincial registration and begin selling its devices as soon as possible. After several F-2-F interactions with the client, we:

identified the devices and/or device groups that should be produced first in order to meet the set timeframe.
advised the client to include ISO 13485 and EC certification in the program, as CE certification is relatively straightforward and the devices produced under this system may be to sell to CE mark region while we were working on Chinese cGMP certification.
proposed the certification strategy i.e., certify the new facility separately from other production facilities, based on the client’s management perspectives.
reviewed the available QMS documents and technical documentation of medical devices.
wrote and compiled Chinese QMS process documents and translated the device documentation by a certified translator.
clarified the audit requirements with the selected third party, a close partner during the ISO audit.
organised advisory meetings with the provincial FDA to clarify product submission requirements and on-site inspection requirements and timeline.

The CE certification was completed after approx. 6 months. This was the 1st milestone for the client, as medical devices manufactured from this new production site could now be exported to the CE-region. The production capacity at the new site for the selected device group was increased by 20% within the first quarter.

The entire program was completed in less than 1.5 years. The new production site was certified according to Chinese GMP (good manufacturing practice) and two device groups were approved for production.