Medical Devices
Quality and Vigilance Ltd stands out as a premier provider for medical device QA services, distinguished by its unparalleled expertise. Our QA expertise serves as a cornerstone for our trusted partners seeking to navigate the complex regulatory landscape of Medical Devices. If you are a start-up or new to the EU Medical Device Regulations, we can support in establishment and implementation of QMS.
MDSAP
MDSAP inspection is a testament to the commitment to international regulatory compliance and quality standards within the medical device industry. We guide you in aligning the QMS with MDSAP requirements and facilitating a seamless inspection experience.
By supporting MDSAP inspections, we exemplify our dedication to helping clients navigate the complexities of global regulatory compliance, thereby fostering a more efficient and harmonized approach to ensuring the safety and efficacy of medical devices on an international scale.
Notified Body Inspection Support
Our expert team is certified in ISO13485:2016 QMS auditors with previous experience of hosting notified body inspections.
We can help you by conducting internal audits as per ISO standards and plan your upcoming audits or inspections by identifying potential compliance gaps and assisting in implementing resolution.
When connected with us, you aren’t fostering growth in the quality of your business alone. We have your back and put in our best to contribute to the growth of your entire systems and processes. So, if you are looking for the right service provider that’ll help you build a good GxP quality presence, we are just a call away.