To sell in the European Union, manufacturers of medical devices must have a Quality Management System (QMS) compliant with the Medical Devices Regulations (MDR and IVDR). Manufacturers must establish, implements, and maintain an effective QMS to ensure that their medical devices meet EU regulatory requirements and perform as intended.
Overall, manufacturers should implement a QMS for the following reasons:
- Ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements.
- Opportunities to enhance customer satisfaction.
- Identification of risks and opportunities.
- Ability to demonstrate conformity to specified quality management system requirements.
Preparing a compliant Quality Management System can be challenging without the help of quality experts. Obelis offers different tailored services to support manufacturers of medical devices and IVDs in preparing a QMS conforming with the MDR or IVDR. Manufacturers can demonstrate compliance with the QMS requirements set in the MDR and IVDR with an ISO certification. Particularly, ISO 13485 specifies requirements for a quality management system for manufacturing of medical devices and related services.
- Trainings on introduction to ISO 13485 – An essential part of ISO 13485 implementation is training of the company staff in their responsibilities and the demonstration of their competences to undertake the activities assigned to them. Obelis will support you in preparation of your ISO 13485 certification. With trainings for ISO 13485 and QMS templates, the manufacturer will be able to compile their QMS documentation for the certification.
- QMS templates and gap analysis checklist – Obelis assists manufacturers in the compilation of the QMS documentation with templates and reviews which will serve as guidance for the establishment, implementation, and maintenance of the QMS.
- Gap analysis follow-up and implementation meeting – Should the manufacturer already have a QMS, Obelis will run gap assessment analysis to identify any shortcomings, and support the manufacturer in addressing these via implementation meetings.
- Experts’ availability and audit simulation – Standardisation organisations accurately assess the compliance of the management system in order to issue an ISO certification. Preparing for an auditing can be stressful and challenging for many manufacturers. Obelis prepares you for the auditing process and simulate actual audits together with our quality experts.
Compliance Success Stories
“We can always count on the quick response of the Obelis team. Managing the huge amount of data necessary for a EU Notification is very complex yet they make is seem so easy.”
“We were under huge time and cost pressure for a new product line launch and we relied on Obelis. It was the right decision. Their expert team helped us to avoid possible regulatory complications.”
“I encourage companies to seek compliance before putting their devices on the market. Working with Obelis to gain swift regulatory approval across several markets has had a profound impact on our company.”
