A Conversation with Alan Schwartz
In industries where product safety, regulatory approval, and quality assurance are essential, navigating compliance requirements has become increasingly demanding. For companies operating in medical devices, pharmaceuticals, biotechnology, food, and dietary supplements, maintaining regulatory readiness requires more than understanding regulations. It demands a well-established quality culture, effective risk management, and a commitment to continuous improvement.
Alan Schwartz, Founder and President of mdi Consultants, has spent more than five decades helping organizations understand and meet these responsibilities. His professional journey began in 1972 as an investigator with the U.S. Food and Drug Administration (FDA), where he developed firsthand knowledge of regulatory oversight, inspection procedures, and the standards companies must meet to demonstrate compliance. In 1978, he founded mdi Consultants to help businesses address regulatory challenges and establish effective quality management systems.
Throughout his career, Schwartz has advised organizations on FDA requirements, ISO certifications, regulatory submissions, quality assurance, and international market access. His work has supported businesses at different stages of development, from emerging companies preparing their first regulatory submissions to established organizations managing complex compliance obligations across multiple countries.
Under his leadership, mdi Consultants has trained more than 15,000 professionals and assisted organizations worldwide with audits, certifications, regulatory submissions, and quality system improvements.
In this interview with Times CEO Magazine, Schwartz discusses how his experience at the FDA influenced his consulting approach, why international regulations continue to challenge businesses, and how organizations can develop sustainable systems that support product quality, patient safety, and long-term growth.
Turning Regulatory Experience Into Practical Industry Solutions
Times CEO Magazine: You began your professional journey as an FDA investigator in 1972 before establishing mdi Consultants in 1978. How did your early experience influence the way you advise organizations today?
Alan: My experience at the FDA gave me an important understanding of regulatory expectations from the perspective of the people responsible for evaluating compliance. I learned that meeting regulatory requirements involves much more than preparing for an inspection. Organizations must establish reliable processes that consistently protect product quality and patient safety.
When I established mdi Consultants in 1978, my objective was to help companies identify potential problems before they became serious compliance issues. I wanted organizations to move away from last-minute preparation and develop systems that were effective in their everyday operations.
Our consulting philosophy is built around preparation, transparency, and ongoing improvement. Having worked within the regulatory system, I understood the weaknesses that could lead to inspection findings and the operational failures that often created unnecessary risks.
That experience helped us develop practical approaches to quality management, regulatory planning, and inspection readiness. We focus on helping clients understand what regulations require and how those requirements can be implemented effectively within their businesses.
Leadership in this field also requires continuous learning. Regulatory expectations evolve alongside technology, manufacturing practices, and public health priorities. Consultants must remain informed and understand how regulatory requirements affect actual business operations.
At mdi Consultants, we believe in establishing lasting relationships with our clients. Our work extends beyond resolving an immediate compliance concern. We help organizations strengthen their quality systems, prepare for audits, manage regulatory submissions, and navigate international requirements with greater confidence.
Understanding the Growing Demands of Global Compliance
Times CEO Magazine: mdi Consultants serves several highly regulated industries across international markets. What are the most significant obstacles companies face when managing regulatory compliance today?
Alan: One of the biggest challenges is the combination of changing regulations and increasingly global business operations. Companies frequently need to satisfy requirements from several regulatory authorities, including those in the United States, Europe, Canada, and other markets.
Although these authorities may share similar objectives, their documentation requirements, approval procedures, and expectations can differ. Organizations must understand these differences while maintaining consistent quality standards throughout their operations.
Technology has added another layer of complexity. Medical devices are becoming more sophisticated, healthcare products increasingly incorporate software, and industries are adopting artificial intelligence, biologics, and additive manufacturing. These developments introduce new considerations involving product safety, cybersecurity, data integrity, risk management, and control throughout a product’s lifecycle.
However, regulatory complexity is only part of the challenge. Companies must also recognize the importance of their internal culture.
Compliance cannot be assigned exclusively to the quality assurance or regulatory affairs department. It requires participation from leadership, engineering, manufacturing, research and development, and every employee whose responsibilities affect product quality.
Organizations need to invest in employee education, process validation, effective documentation, and regular performance monitoring. These activities help ensure that compliance becomes part of daily operations rather than an activity performed only when an inspection approaches.
At mdi Consultants, we have trained more than 15,000 professionals because we understand that knowledgeable employees are essential to maintaining effective and sustainable compliance programs.
The Common Reasons Organizations Fall Short During Inspections
Times CEO Magazine: With decades of experience supporting FDA inspections and ISO certifications, what recurring problems do you see when companies prepare for regulatory audits?
Alan: A frequent problem is the belief that inspection readiness can be achieved through a short period of preparation immediately before an audit. In reality, readiness must be maintained continuously.
When organizations postpone important compliance activities until an inspection is approaching, weaknesses often become apparent. Experienced investigators can usually distinguish between a quality system that functions effectively and one that has been organized primarily to create a favorable impression during an audit.
Documentation is another critical area. A company may carry out its manufacturing or operational activities correctly, but incomplete records can undermine its ability to demonstrate that the work was performed according to established procedures.
Procedures, validation activities, deviations, investigations, and corrective actions must be documented accurately and consistently. Without appropriate records, regulators may question whether the organization has adequate control over its processes.
Employee preparation also matters. During inspections, staff members may become nervous or provide inconsistent information if they do not fully understand their responsibilities or the procedures they follow.
This is why we encourage organizations to conduct mock inspections, strengthen internal communication, and provide employees with practical training. People should understand their roles well enough to explain their work clearly and accurately.
Our objective is to help companies develop the knowledge, confidence, and operational discipline needed to manage regulatory scrutiny effectively. Members of the mdi Consultants team have participated in numerous FDA and ISO audits, providing practical experience that helps organizations prepare for the inspection process.
Risk management is equally important. Companies must identify potential problems, evaluate their possible consequences, and implement appropriate controls before those problems affect product quality or patient safety.
The FDA’s Quality Management System Regulation, known as QMSR, reinforces the importance of a structured quality management approach for medical device manufacturers. Risk analysis and risk-based decision-making are important considerations throughout design, manufacturing, and related operational activities.
Organizations that integrate risk management into their everyday processes are generally better positioned to identify weaknesses early, respond to emerging issues, and demonstrate effective control during inspections.
Why Preparing for Regulatory Changes Early Matters
Times CEO Magazine: mdi Consultants emphasizes staying informed about regulatory developments and preparing for changes before they become urgent. How does this approach benefit businesses?
Alan: Regulations and regulatory expectations continue to develop as new technologies emerge, scientific knowledge advances, and public health priorities change.
Companies that wait until a new requirement becomes mandatory may find themselves under pressure to revise procedures, update documentation, retrain employees, or redesign aspects of their quality systems within a limited timeframe. These efforts can become expensive and disruptive when they have not been planned properly.
Being involved in regulatory developments can help organizations understand the direction in which requirements are moving. Our experience with areas such as the development of HACCP regulations has reinforced the value of recognizing emerging expectations and preparing for their potential impact.
Early preparation gives businesses more time to evaluate what changes may mean for their operations, allocate resources, and implement appropriate solutions without unnecessary disruption.
It can also provide commercial advantages. Companies with well-developed compliance systems may be better positioned to pursue market access, complete audits efficiently, strengthen customer relationships, and demonstrate credibility to investors and business partners.
Compliance should not be treated simply as an expense or an administrative obligation. When integrated into business planning, it can improve operational consistency, strengthen risk controls, and support more informed decision-making.
At mdi Consultants, we continually review our training programs, audit preparation methods, regulatory submission strategies, and consulting practices to reflect developments in the industries we serve.
Maintaining regulatory readiness is an ongoing responsibility. Organizations that commit to learning and improvement are better equipped to respond to change and sustain their performance over time.
Helping Emerging Healthcare Companies Establish a Strong Foundation
Times CEO Magazine: What recommendations would you offer startups and growing medical technology companies preparing to enter regulated markets?
Alan: My first recommendation is to establish a strong quality management system as early as possible.
Many emerging companies concentrate their resources on research, product development, and innovation while postponing regulatory planning. This can create significant difficulties later because quality controls, risk management, and regulatory considerations need to be integrated into development activities from the beginning.
Entrepreneurs may not always recognize how extensively regulatory requirements can influence product development, manufacturing decisions, budgets, and commercialization timelines. Understanding these obligations early can prevent costly setbacks.
My second recommendation is to seek guidance from experienced regulatory professionals who understand both regulatory strategy and practical implementation. Companies need a realistic roadmap that identifies the applicable requirements, necessary documentation, potential risks, and expected milestones.
Whether an organization is pursuing a 510(k) submission, Premarket Approval (PMA), CE marking, or another applicable regulatory pathway, early planning is essential. The appropriate strategy depends on the product, its intended use, its classification, and the requirements of the target market.
Third, companies should invest in employee education. Training should go beyond explaining which procedures employees must follow. People need to understand why those procedures exist and how their responsibilities contribute to product quality, compliance, and patient safety.
An informed workforce is better prepared to identify problems, follow established controls, and respond effectively when processes or regulatory expectations change.
Finally, businesses must remember the fundamental purpose of regulation. Regulatory requirements are intended to help ensure that products meet applicable standards for safety, quality, and performance.
Organizations that make these principles central to their decision-making are more likely to establish dependable processes and build lasting credibility with customers, regulators, and business partners.
Moving quickly toward commercialization without an appropriate regulatory strategy can create unnecessary risks. Companies should approach market entry with a clear plan, experienced guidance, and a quality system capable of supporting future growth.
The strongest foundation for long-term success is built through preparation, accountability, employee engagement, and a consistent commitment to improvement.
Quality and Compliance as Drivers of Long-Term Business Success
As healthcare innovation accelerates and regulatory requirements continue to expand across international markets, organizations must find effective ways to balance product development with quality assurance, regulatory readiness, and patient safety.
Alan Schwartz’s career reflects the importance of combining regulatory knowledge with practical implementation. From his early experience as an FDA investigator to his leadership at mdi Consultants, he has worked to help organizations understand their obligations, strengthen internal systems, and approach compliance as an integral part of business operations.
Through its consulting, training, audit support, and regulatory services, mdi Consultants continues to assist companies across medical devices, pharmaceuticals, biotechnology, food, and dietary supplements in addressing complex regulatory challenges.
A central principle of Schwartz’s approach is that effective compliance cannot be achieved through documentation alone. It requires leadership commitment, informed employees, well-designed processes, meaningful risk management, and consistent oversight.
For companies seeking to enter new markets or expand their operations, these elements can help establish a stronger foundation for sustainable growth. They also support the broader objective of ensuring that products reaching customers and patients meet the applicable expectations for quality, safety, and reliability.
Ultimately, regulatory excellence is not a one-time achievement. It is an ongoing organizational commitment that requires businesses to evaluate their performance, learn from experience, adapt to changing requirements, and continually strengthen their systems.
For Schwartz, the long-term value of compliance lies in building organizations that customers, regulators, and patients can trust.
Learn more about mdi Consultants: https://mdiconsultants.com
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