Quality of product is not a destination but a journey. Focus and commitment to quality has to be incorporated into everyday operation at every level in your medical device and IVD company to truly produce quality products and consistently meet the various mandatory requirements of ISO 13485, FDA QSR, MDSAP or any other applicable standard.
While many medical devices and IVD companies understand the importance of a Quality Management System (QMS), but often the QMS that is set up internally (using templates) is widely different from the actual practices. This is a gap that Elexes has been addressing and has been facilitating in obtaining complete compliance and ISO 13485 and MDSAP certifications that in a true sense prove to be a value addition in the long term for medical devices and IVD companies.
Elexes’ involvement can help you streamline your processes and set up optimized efficient systems with well-defined responsibilities and accountability.
Quality Systems & Compliance Services
We provide customized quality system solutions that are tailored to your organization, because when it comes to quality systems “one size does not fit all”. Amongst the various premarket and post-market quality systems support that Elexes has provided, the following have been the most popular ones:
- Quality systems setup (ISO 13485/QSR/MDSAP)
- Document control system set up
- Validation of various software involved in the QMS
- Document Controller appointment
- Internal Audit
- Training sessions for ISO 13485, MDSAP, IEC 62304, ISO 14971
- Supplier audits & monitoring
- Managing external parties for mergers, acquisitions, and deals
- Maintenance of Quality Systems as per the ISO 13485/21 CFR Part 820/MDSAP
- FDA inspection
- Gap assessments
- Unique Device Identification (UDI)
- CAPA management
- Annual renewal of company’s registration
- Annual renewal of listing & agents
- Complaint handling & reporting
With Elexes’s support and guidance to get the right audits and inspections scheduled for appropriate certifications, you can demonstrate to your investors, partners, and customers that your medical device and IVD company is willing to go above and beyond for quality.
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