ISO 13485 is a quality standard that provides the framework for meeting medical device requirements in the international marketplace. It specifically covers the requirements for a Quality Management System for companies that produce Medical Devices. This is a combination of ISO 9001 with requirements for medical devices added on to the basic Quality Management System.
The Strategy
Rapid advances in medical devices, new technologies and increased global regulatory requirements have placed considerable challenges that companies face, as market entry requirements for each product and market. As a manufacturer, you want to ensure that your goods are effective and safe for consumer use, and you want to be efficient enough to take your product overseas as a benefit, not a cost. Your QMS must be compliance and effective.
The Rewards of ISO 13485
ISO 13485 generates increased communication, process efficiency, employee involvement, continuous improvement, and overall business excellence. Your success is a function of the use of these techniques and makes preparations for compliance easier now and for the future.
Our staff has more than 20 years experience in the implementation of quality management systems and managing compliance issues.
The QPS team provides:
- Coaching and hands-on guidance to team leaders and team members through successful registration
- Structured classroom training in practical, hands-on techniques needed
- to understand and manage a successful and efficient quality system
- Assistance in developing an appropriate implementation
- Enhanced participant skill sets within the organization to drive quality system improvements, remedy urgent problems from regulatory bodies and deliver effective system.
The QPS Advantage
Our program enables you to get your products to market quickly and to maintain your compliance status. As professional consultants to the Medical, healthcare and other industries, QPS helps companies to achieve and maintain compliance, improve overall systems and provide internal auditing services.
Using our established and practical training techniques, QPS provides the consulting and training that clients needed.
Our experience includes numerous audits for compliance registration for a wide range of products and devices. We know what ISO registrars expect from your quality system and can help you develop a quality system that is simple, practical, and effective in maintaining your objectives to comply with ISO requirements.
We are committed to deliver, with support unrivaled by others. Contact us today and find out why so many businesses trust QPS for their success.