quality management system
How robust is your current QMS?
How often do you review it?
Are you confident that your QMS is not at risk without an expert’s view?
The heartbeat of any medical device business is its Quality Management System (QMS). It is the keystone upon which you build thorough innovative design principles and strong manufacturing protocols. This ensures that your device is crafted efficiently and is effective and safe to use, whilst satisfying customer expectations and complying with regulatory requirements.
Key processes critical to any QMS must include:
• Document and Record Control
• Supplier Control
• Management Review
• Corrective and Preventive Action
• Internal Auditing
• Risk Management
IMed’s team members have extensive experience and success in a variety of IVD and Medical Device organisations, from SME to global leaders. This means that we can provide you with solutions which will ensure that your business is compliant to the very latest QMS requirements such as: ISO 13485, 21 CFR Part 820 and MDSAP.
A robust QMS is fundamental to achieve excellent working practices, which will deliver consistent results and underpin the success of your device and the reputation of your business. We can help you reduce your risk with diligent QMS delivered by experts.