Contributions for the April Issue of The Demix Best Practice Magazine
Submit your article about (MBR) Managing Business Resilience - (RSK) Risk and Opportunity Management, (IRP) Incident Resolution & Prevention, (CONT) Continuity for next month's issue.
Send your Articles / Presentations / Tools to This email address is being protected from spambots. You need JavaScript enabled to view it.
In this issue we will cover the following;
(PMW) Planning and Managing Work - (EST) Estimating, - (PLAN) Planning, - (MC) Monitor and Control
(PMW) Planning and Managing Work This CA involves determining the amount of work that needs to be done, planning and scheduling of the work, and then ensuring the work is being done in accordance with the plans and schedules. It also ensures that resources are adequate to meet the plan and schedule.
(EST) Estimating Includes forecasting the effort, size, and cost for the work required to develop, acquire, or deliver the solution.
(PLAN) Planning Involves:
Using the estimates to develop a work plan, schedule, and budget
Determining the necessary resources to accomplish the plan within schedule and budget
Obtaining commitment to the work plan from stakeholders
(MC) Monitor and Control Provides an understanding of progress so appropriate corrective actions can be taken when performance deviates significantly from the plan, schedule, and budget
Medical Device Discovery Appraisal Program (MDDAP)
Article: Enhancing Medical Device Quality and Compliance: The Role of MDDAP by Johann (Elmo) Scheffer (Demix ATL/MDDAP ATM)
Enhancing Medical Device Quality and Compliance: The Role of MDDAP The Medical Device Discovery Appraisal Program (MDDAP) is reshaping how medical device manufacturers approach quality, efficiency, and regulatory compliance. This voluntary initiative, built on the Capability Maturity Model Integration (CMMI) framework, offers a structured approach to process improvement across key areas such as design, manufacturing, and quality management. By adopting MDDAP, companies can move beyond traditional compliance-focused methods and embrace a proactive strategy that fosters continuous improvement. Understanding MDDAP’s Place in the Regulatory Landscape To fully grasp the impact of MDDAP, it’s essential to see how it fits into broader industry initiatives:
Medical Device Innovation Consortium (MDIC): A public-private partnership dedicated to advancing medical device quality and innovation. MDIC collaborates with regulatory bodies, manufacturers, and other stakeholders to drive best practices in the industry.
Voluntary Improvement Program (VIP): An FDA-supported initiative that emphasizes continuous improvement over punitive compliance measures. MDDAP operates under the umbrella of VIP, allowing participating companies to benefit from a more collaborative, improvement-driven regulatory environment.
Why Should Medical Device Companies Participate in MDDAP? The medical device industry is one of the most regulated sectors, with companies constantly navigating complex compliance requirements while striving for efficiency and innovation. MDDAP offers several key advantages that make it an attractive option for organizations looking to stay ahead of regulatory demands while optimizing their processes.
1. Regulatory Advantages Unlike traditional regulatory audits, participation in MDDAP is recognized by the FDA, often leading to fewer routine inspections and more efficient regulatory interactions. Companies that engage in MDDAP demonstrate a commitment to continuous improvement, which can facilitate smoother compliance processes and faster approvals.
2. Process Optimization and Efficiency By leveraging the structured assessment methods of CMMI, MDDAP helps organizations identify process gaps, enhance operational efficiency, and reduce defects. This proactive approach to quality management not only improves product reliability but also minimizes costly production delays and rework.
3. Market Competitiveness and Brand Reputation Medical device companies that excel in quality and efficiency gain a competitive edge. Participation in MDDAP signals to customers, investors, and regulators that a company is committed to best practices, reinforcing trust and strengthening brand reputation in a highly competitive market.
4. Cost Savings Through Proactive Compliance Traditional regulatory compliance can be costly and reactive, often involving significant financial resources to address unexpected deficiencies. MDDAP fosters early issue detection and resolution, reducing overall compliance costs, minimizing waste, and preventing regulatory setbacks.
5. A Collaborative Approach with the FDA Unlike traditional compliance frameworks that may feel adversarial, MDDAP encourages a constructive dialogue with regulators. Instead of waiting for compliance issues to trigger enforcement actions, companies participating in MDDAP engage in ongoing improvement efforts alongside the FDA, fostering a more transparent and cooperative relationship.
The Future of Medical Device Quality Management The MDDAP initiative represents a significant shift in how the medical device industry approaches quality and compliance. By emphasizing continuous improvement, proactive risk management, and collaborative engagement with regulators, the program provides a pathway for companies to enhance their operations while staying ahead of regulatory challenges. For medical device manufacturers seeking to improve efficiency, ensure compliance, and strengthen their market position, MDDAP offers a compelling opportunity. Instead of merely reacting to regulatory pressures, companies can take charge of their quality journey—resulting in better products, streamlined processes, and a more resilient business model. Would you like to learn more about how MDDAP can benefit your organization? Feel free to reach out for more information on how to get started.
Agile - (PMW) Planning and Managing Work - (EST) Estimating, - (PLAN) Planning, - (MC) Monitor and Control
Overview on Agile Planning Agile Planning. It sounds like a paradox, doesn’t it? Planning involves setting boundaries, creating checklists, determining delivery dates, and following a step-by-step process, doesn’t it?
But Agile, isn’t that all about people doing their own thing? Many people think of traditional planning as the musical equivalent of a disciplined classical orchestra and Agile Planning as the free-form chaos of jazz.
Nothing could be further from the truth.
This article will explain why Agile thinking and planning are not exclusive and can work together powerfully for your business.
Taking the time to plan and make decisions as part of a broader strategy improves every aspect of your business, including your workforce. Despite the size or type of company, workforce planning is a valuable HR process that ensures you have the staff to execute your business strategy.
Learn what workforce planning is, how it helps with goals and produces positive outcomes, the benefits it can offer, five key steps in workforce planning, and what it looks like in practice.
As evident from the title itself, it’s a process that tracks the actual project performance with the planned Project Management activities. The monitor and control process is a control function that takes place at all stages of the project – from Initiation through Closing. The key benefit of this process is that it allows the stakeholders to understand the current state of the project, the steps taken, and the budget, schedule, and scope forecasts.
Monitor And Control Process Through the process of monitor and control, the project manager must be in a position to balance the requirements that arise from different knowledge areas. For example, the project manager can undergo situations, where a project is completed on time, but, has failed to meet the quality standards mentioned in the Project Management plan. Likewise, the project might have a significant scope, but unfortunately, it has exceeded the time and cost limit. Hence, the process of monitoring and controlling project work is considered extremely important.
Planning helps an organization chart a course for the achievement of its goals. The process begins with reviewing the current operations of the organization and identifying what needs to be improved operationally in the upcoming year. From there, planning involves envisioning the results the organization wants to achieve and determining the steps necessary to arrive at the intended destination – success, whether that is measured in financial terms, or goals that include being the highest-rated organization in customer satisfaction.
One enterprise can own millions of videos, presentations, documents and other forms of information from different data sources. But is it easy to find what you are looking for from that mass of data?
And what about structuring and categorizing the data? If your company has 10,000 hours of video, it’s not really realistic for people to carefully go through and categorize that amount of content. The videos are searchable only by the titles and short descriptions, and the actual video content remains out of reach for the search engine.
According to a McKinsey report, employees spend 1.8 hours every day searching and gathering information. On average, that’s 9.3 hours per week!
Current enterprise search solutions lack efficiency and end up wasting hours of precious time.
Staying one step ahead in cybersecurity is a constant challenge that many organizations must navigate. Even the most intricate and unsuspecting of vulnerabilities often lurk in plain sight, with seasoned cybersecurity professionals overlooking them with relative ease. It is easy to say that maintaining constant vigilance should always remain a high priority, but a more salient lesson is that knowledge is power.
Understanding what vulnerabilities exist, along with their potential severity and impact, can dramatically strengthen an organization’s cybersecurity posture and improve overall cyber readiness. Among these vulnerabilities are seemingly harmless features that can pose significant risk if not properly managed. One such risk is Exchangeable Image File Format (EXIF) metadata—a hidden but quintessential feature of digitized images that can potentially open the door for malicious actors.
It is prudent to understand how this type of hidden information poses a wealth of cybersecurity implications. When it comes to risk-based information security,1 understanding all there is to know about EXIF data should be a priority. Proactively addressing this risk can prevent the need for reactive measures following a cyberbreach.
Editor’s note: This is the second in a weeklong series of ISACA Now blog posts sharing guidance on how to start 2025 strong across digital trust professions. Today, we focus on risk.
As we look ahead to 2025, risk professionals face a landscape characterized by macroeconomic, geopolitical and regional uncertainties. The evolving nature of risks requires a proactive and strategic approach to start the new year strong.
The global economy continues to face challenges driven by political instability, trade tensions and regional conflicts. These uncertainties demand that risk professionals stay informed and agile in their decision-making processes.
Below are five key strategies that risk professionals should prioritize for success in 2025.
1. Leverage Reliable Information Sources
The current political instability and the diverse forces at play are significantly affecting the decision-making process due to an information void and the prevalence of disinformation in this era. Obtaining high-quality security information is increasingly challenging, complicating risk assessments for personnel, facilities, and projects, as well as the development of effective mitigation strategies.
When I first stepped into my role as a cybersecurity incident responder, I quickly discovered that speed and consistency can make or break an organization’s defense. With the surge in both the complexity and volume of cyberattacks, it’s not enough to rely on manual, human-driven processes anymore. Automation has become a game-changer in incident response, and in this post, I want to explore what that looks like in practice.
Laying the Foundation: Key Components of an Incident Response Plan
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