Appraisers can now become trained and certified in the Medical Device Discovery Appraisal Program (MDDAP) through a mix of coursework, observations and apprenticeships.

Schaumburg, IL—MDDAP is empowering professionals with new opportunities to excel in the medical device sector through a cutting-edge learning pathway designed for the Voluntary Improvement Program (VIP). This initiative provides essential certifications leveraging the Medical Device Discovery Appraisal Program (MDDAP), equipping appraisers to grow in their careers, access new revenue opportunities, and contribute to continuous improvement efforts within the industry.

MDDAP is a tailored version of the CMMI framework and provides a model and method by which medical device manufactures can better understand, measure, and improve their capability to develop high quality devices. VIP, which is a specialized program developed in tandem with the FDA, the medical device industry, and the Medical Device Innovation Consortium (MDIC), uses MDDAP as a key component to support medical device makers.

The MDDAP certifications entail a mix of coursework, observations, and apprenticeships for those who want to become an MDDAP Appraisal Team Member (ATM) or MDDAP Appraisal Team Lead (ATL). MDDAP launched the ATL certification at the end of March with the development of a new self-paced, eLearning course and Observation process, opening the door for MedTech professionals to join the growing community of MDDAP appraisers.

“Through this new learning pathway, those earning an MDDAP certification not only have the potential to expand their business offerings, reach new clients, and become more skilled in their profession with new training, but also have the opportunity contribute to the safety and efficacy of medical devices and patient outcomes,” says Kim Kaplan, ISACA Principal Product Manager, MDDAP.

Becoming an MDDAP Appraisal Team Member (ATM)

For those wanting to become an MDDAP Appraisal Team Member (ATM)—an individual who has the prerequisite experience and training to participate and support an appraisal of an organization against the MDDAP tailored view of the CMMI framework—the certification is valid for a three-year period upon completing the following steps.

1. After applying and then completing a program interview, prospective MDDAP Appraisal Team Members (ATMs) then continue with two classes—the Building Organizational Capability course, a virtual, four-day introductory course, and the MDDAP Concepts eLearning course, which prepares learners to participate in an MDDAP appraisal.
2. After the candidate completes a professional services agreement, they move to the ATM observation stage, an in-the-field evaluation of candidates during which they apply the knowledge they obtained during training.
3. Lastly, during the apprenticeship stage, individuals engage in on-the-job training with a coach over the course of one to four additional appraisals.
4. After becoming an MDDAP ATM, certified individuals will be able to facilitate discussions, generate notes, and validate and obtain consensus around results.

Becoming an MDDAP Appraisal Team Lead (ATL)

After earning their MDDAP ATM certification, interested individuals can pursue the MDDAP Appraisal Team Lead (ATL) certification, expanding the pool of professionals eligible to earn the credential.

1. After applying for the ATL certification, candidates participate in the Medical Device Discovery Appraisal Program (MDDAP) Appraisal Team Lead Training Course, which prepares them to lead an MDDAP appraisal. The course covers MDDAP appraisal quality and ethics, the roles and responsibilities of appraisal participants, how to use the MDDAP Method Definition Document (M-MDD), how MDDAP appraisals can be used to evaluate and improve business performance, and the key aspects of the MDDAP appraisal approach.
2. Learners will complete this course feeling prepared to lead their first MDDAP appraisal and ready to schedule their ATL observation.
3. Following this observation, candidates are offered additional coaching through an apprenticeship stage to earn their ATL certification.

Individuals who complete the ATL certification will be able to lead an appraisal of an organization against the MDDAP tailored view of the CMMI Framework, including scoping the level of effort, setting the objectives, creating the plan, schedule, logistics, resource management, and risk mitigation - plus managing the appraisal team to support the effort.

Another path to the ATL is the MDDAP Appraisal Team Lead Bootcamp, which takes prospective ATLs on the full journey from Building Organizational Capability through Appraisal Team Lead Coaching in one year.

“Those who pursue this learning pathway have the opportunity to be on the ground floor of a growing and developing program,” says Simona Rollinson, ISACA Chief Operating Officer. “MDDAP certification holders will be able to work with some of the top medical device manufacturers around the world—helping these organizations build capability to save lives and produce higher quality products.”

Learn more about VIP and MDDAP here: https://www.isaca.org/mddap#overview. More information about the MDDAP learning pathway can be found at https://www.isaca.org/mddap#become-an-appraiser.

About MDDAP^® LLC

MDDAP LLC is advancing quality and patient safety in the medical device industry through a tailored version of the globally recognized CMMI performance improvement framework. MDDAP empowers device makers to look beyond compliance and toward continuous improvement to elevate quality, drive innovation and increase performance. MDDAP is leveraged as the model and appraisal method in the Voluntary Improvement Program, part of FDA’s Case for Quality initiative. To learn more about MDDAP, a subsidiary of digital trust association ISACA, visit www.isaca.org/vip. 

Contact:

communications@isaca.org
Emily Ayala, +1.847.385.7223
Bridget Drufke, +1.847.660.5554