Irrespective of device classification, a Quality Management System is the cornerstone of the life cycle development of all medical devices. A robust QMS is necessary to meet both customer and regulatory requirements.
DevDx has extensive experience with the successful implementation of a QMS for multiple types of medical devices, IVDs, diagnostics and software. We have worked with a range of start up companies, academic and research organisations, SMEs, and multinationals.
Regardless of where you are in the life cycle development pathway for your product, DevDx can quickly assess your needs and offer a bespoke, cost-effective, and best practice solution.
Whether you need a fully compliant system to gain certification and regulatory approval or just an in-house data driven system to ensure control of your product development, we can help.
We have been developing, implementing, training, and maintaining Quality Management Systems for over 20 years. We have a special interest in and extensive experience working with Australian start-up companies.
“We have done it before, so we understand how to bootstrap your QMS”. Our successful track record speaks for itself.
DevDx ensures that your QMS is fully compliant to ISO 13485:2016, FDA 21 CFR 820 (including the new FDA QMSR), the MDR (2017/745), IVDR (2017/746) and prepared for a Medical Device Single Audit Program inspection.
We also have broad experience in the implementation of QMS compliant to ISO 9001, ISO 15189, and other standards.
Our services:
- A fully developed suite of QMS operational procedures (out of the box), internally cross-referenced to ensure compliance to ISO 13485:2016, 21 CFR 820 and MDR/IVDR
- Bespoke QMS consistent with company size, medical device classification, regulatory pathway, and company budget
- Development of a system (from Day 1) that meets ALL regulatory jurisdictions (whether paper-based or an eQMS)
- Bootstrapping your QMS for start-up companies
- Accelerated pathway to implementation and audit readiness
- Process mapping and gap analysis
- Various eQMS solutions to fit your company structure and budget. We can offer special pricing based on your selection of system
- Exclusive access and preferred pricing for Ideagen Quality Management Professional QMS Software
- Joint development with your staff or coaching staff to become fully independent
- Acting as your Quality Management Representative and/or Person Responsible for Regulatory Compliance
- Conducting regular inhouse, pre-inspection audits and navigating certification audits
- Vendor audits and qualification
- Pre- and post-market responsibilities
