Medical Device Compliance Total Solution
Significant changes are taking place in the medical device industry. The changeover to ISO 13485:2016 and the European transition from Medical Device Directive (MDD) to Medical Device Regulation (MDR) is creating risk and huge work for medical device manufacturers and also authorised representatives. We have developed a flexible support offering to work closely with you to obtain rapid cost-effective compliance using experienced medical device experts, compliant software and a common management approach based on delivery of expertise globally and local on-site support to ensure the work gets completed as quickly as possible and right first time.
Pre-Compliance Design Review:
Ideal for early and pre-certification compliance review. We can assess your current design against 60601 2nd and 60601 3rd editions. At the end of our review, you will receive a comprehensive report detailing the non-conformances. But, we don't stop there...we will also provide cost-effective compliance design recommendations to meet the applicable 60601 requirements.
Coordinate Formal Certification with Agencies/Regulatory Bodies:
We have established a strong relationship with major Nationally Recognized Testing Laboratories (NRTLs) and Notified Bodies that can work to your advantage in terms of potential compliance cost reduction and expedited certification services. In addition, our prior experience working directly with major Agencies will provide inside know-how on their processes. We can assemble the relevant documentation needed to efficiently certify your products and expediently coordinate the whole certification process with your chosen agency.
Gap Analysis and Proposal Generation
Evaluating your management system to determine your current level of compliance with ISO 13485:2016. The gap analysis supports the development of a list of action items to adopt the new standard, also known as a quality plan and will involve friendly audit of gaps and readiness where we operate as part of your team and can implement resources to match your needs depending on your internal resource availability.
A quality plan enshrines the goals and tasks your organisation must accomplish to comply with ISO 13485:2016. Part of the changes is that there is more focus on quality planning in the new standard.
Risk Based Approach
ISO 13485:2016 places much more emphasis on risk management. Utilising the best practise in ISO 14971 and ISO 13485 we can offer a compliant software based QMS and risk management system which can remove the admin burden and complexity as your company grows. We can implement this software and train your staff to take over at the end of the project so that you can manage the system internally or we can stay with you during your journey and support the QMS management until you are ready to take over.
Compliance Design Input throughout Product Development
It is important that 60601 requirements are integrated as early as possible throughout product development. The idea is, once it's all said and done, is to have a compliant product prior to submitting for certification. We can work directly with your design teams and provide inputs from 60601.
If you plan to complete the work necessary to upgrade in-house, LUX-IEC can perform a pre-assessment audit prior to your Notified Body certification audit.