Join in for MDSAP Training with QMII
Are you looking for a way to ensure your medical device is compliant with international standards? Then MDSAP, Medical Device Single Audit Program, is the answer. This program allows manufacturers to be assessed and monitored by a single regulatory body, which significantly reduces costs and streamlines the audit process. QMII is now offering MDSAP training courses that focus on the requirements of the program and how to successfully implement it in your organization. Join us as we explore what this program can offer and how you can benefit from it through our upcoming training sessions.
The Medical Device Single Audit Program (MDSAP) is an internationally recognized quality management system for the manufacture of medical devices. The program provides a single audit of a company's quality management system by multiple regulators, instead of separate audits by each regulatory authority.
The MDSAP program was created in response to the growing global trend of medical device companies manufacturing products for multiple markets. The program consolidates the requirements of multiple regulator audits into a single process, which reduces duplication and wasted effort on the part of both industry and regulators.
MDSAP-recognized Auditing Organizations (AO) conduct audits against the requirements of ISO 13485, as well as any additional national or regional requirements that are specified by the participating authorities. AOs must be accredited by a recognized accreditation body to perform MDSAP audits.
In order to participate in MDSAP, medical device companies must first register with a QMII-approved AO. Once registered, companies will undergo an initial assessment audit, followed by annual surveillance audits. Participation in MDSAP is voluntary, but many companies choose to participate in order to simplify their regulatory compliance obligations.
What is MDSAP?
MDSAP is the Medical Device Single Audit Program, a program led by Health Canada that harmonizes the process of medical device audits for companies registered in multiple jurisdictions. The MDSAP program allows companies to receive a single audit from an MDSAP-recognized Auditing Organization (AO), which would satisfy the requirements of multiple participating regulatory authorities: Australia, Brazil, Canada, Japan and the United States. The goal of MDSAP is to reduce redundant auditing requirements and improve efficiency in how medical device companies are regulated globally.
The MDSAP program started in January 2015, and since then many companies have taken advantage of this opportunity to streamline their audit processes. QMII is proud to be an MDSAP-recognized AO, and we offer MDSAP training courses to help companies prepare for their audits. Our courses cover all aspects of the MDSAP program and provide valuable tips on how to effectively manage your company's global regulatory compliance burden.
If you're interested in learning more about MDSAP or signing up for our training course, please contact us today!
What is QMII?
QMII is a quality management system that provides a framework for organizations to manage their quality assurance activities. It is based on ISO 9001, but also incorporates other international standards such as ISO/IEC 17025 and ISO/IEC 27001. QMII is designed to help organizations improve their quality management processes and practices, and to ultimately improve the quality of their products and services.
MDSAP Training Details
MDSAP training details are as follows:
1. The training will be held on Saturday, May 12th from 9:00am to 4:00pm at QMII's office in Toronto.
2. The cost of the training is $750 + HST per person.
3. Attendees will receive a certificate of completion at the end of the training.
How to register for MDSAP Training?
Registration for MDSAP training is easy and can be done online. To register, simply visit the QMII website and click on the “MDSAP Training” link. From there, you will be redirected to a page where you can select the type of training you are interested in.
Once you have selected the type of training you would like to take part in, simply fill out the form with your contact information and desired start date. Once your registration has been processed, you will receive an email confirmation with further instructions on how to access the training materials and begin your coursework.
Why choose QMII for the MDSAP Training?
There are many reasons to choose QMII for MDSAP training. We offer a comprehensive and flexible program that can be customized to meet your specific needs. Our team of experts have years of experience in the medical device industry and are familiar with the latest regulatory requirements.
We also offer a wide range of services to support you during and after the training, including:
-A dedicated account manager to help you plan and organize your training
-Customized training materials and support tools
-Access to our online learning portal and library of resources
-Ongoing technical and regulatory support after the training
MDSAP is a valuable program for medical device companies to demonstrate their commitment to patient safety and compliance with global regulatory requirements. With MDSAP training from QMII, you can ensure that your organization is fully prepared for the rollout of this new system and be ready to comply with the latest standards. Take advantage of our experienced team of professionals and join us in preparing your business for success through MDSAP training today!