Optikos Achieves Zero-Finding
ISO 13485 Recertification: A Conversation with Nick Mastrocola, Quality Manager at Optikos

Expertise in engineering goes hand in hand with a rigorous application of high-quality standards. For the life science and diagnostics sector, these quality checks ensure the safety, reliability, and efficacy of medical devices and applications throughout their lifecycle.  

Recently, Optikos has successfully completed its ISO 13485 recertification with zero non-conformities. This is a significant achievement in the highly regulated life sciences sector. We spoke with Nick Mastrocola, Quality Manager at Optikos, about what this milestone means for our customers and the industry overall.

Q: Congratulations, Nick, on the successful recertification. Can you explain what ISO 13485 represents for your work?

Nick Mastrocola (NM): Thank you, well, ISO 13485 is the international standard for medical device quality management systems. It’s been over six years since our initial certification, and this marks our second recertification. The audit requires a full review of our entire quality management system. This is something that gets scheduled every three years, with surveillance audits in between. For medtech specifically, this is a critical process. Especially for Class 2 and Class 3 devices that face intense FDA (the US Food and Drug Administration) scrutiny. Additionally, the auditors we get at Optikos have extensive industry experience and understand exactly what compliance looks like, so the audits are rigorous and detailed.

Q: Optikos achieved zero findings in this recent recertification. What does that actually mean for our operations and clients?

NM: It means there were no findings requiring corrective actions after the audit.  Auditing is based on sampling so there could be nonconformities that exist that were not identified. But it is our practice to evaluate any comments or opportunities presented to us for continuous improvement purposes. Receiving zero findings confirms that our quality system is robust. More importantly, it signals to potential employees and partners that Optikos maintains solid regulations and procedures throughout our entire operational framework. This is a strong indicator of organizational maturity.

Q: What specific improvements in activity led to this outcome?

NM: Since our last recertification, we focused heavily on process validation on the production floor and enhanced control plans across production lines. Beyond checking boxes, the new measures we implemented provide real value by making manufacturing run more smoothly. We’ve become very proactive when setting up new lines and bringing in new products into the facility. What sets us apart at Optikos is that quality measures have been embraced by everyone in the company. They’re not just mandates that come from the Quality department. I feel our zero findings outcome speaks volumes to how this approach has been a successful development.

Q: How did the Optikos team prepare for such a rigorous audit?

NM: Being audit-ready year-round, to be honest. There shouldn’t be weeks of chaos that we’re trying to clean up before an auditor arrives. The audit should be just like any other day. If someone asks for documentation during the audit process, it’s provided immediately without scrambling. You get that when everyone already adopted an ”audit-ready” mentality.  Such promptness shows good management and system integrity. Moreover, the documentation example is a real thing that happened. When auditors requested design project information, I called an engineer into the conference room. Within five minutes they were prepared to discuss everything without quality management intervening. Such scenarios demonstrate true system understanding across the board. Additionally, manufacturing personnel interacted directly with auditors too, which builds confidence that everyone in the business understands the processes they execute daily.

Q: Your career spans 30 years across defense, semiconductors, and medical devices. So, what makes Optikos different?

NM: I have worked with many big medical device companies. The experience gave me a solid foundation on how to build a robust quality management system. But what makes a difference in the end are the people and how they adopt change and foster continuous improvement. What stands out at Optikos is the commitment from senior leadership compared to your average company. Dr. Steve Fantone, the founder of Optikos, has prioritized this consistently from the beginning. This makes my job significantly smoother nowadays. People buy into what they see gets promoted by the leadership team, which in this case is a genuine appreciation for quality management system and positive management commitment.

Q: How does this ISO recertification impact the confidence of life science and diagnostics companies relying on Optikos for their optical components?

NM: In medtech, there’s always a balance between necessary rigor and bureaucratic overhead. You don’t want to build a quality management system that does not work for you or the customer base. You don’t want to overdo it, but you don’t want to underdo it either, especially when dealing with complex Class 2 or Class 3 devices. For our partners, knowing that we have third-party certification means they are working with an organization where quality is deeply and naturally embedded in our daily operations. When a new employee joins us, they enter a structured environment where processes are clear and consistent, not chaotic. Accordingly, we’re proud to deliver precision optical components that are built on a healthy foundation. This foundation is thoroughly vetted by experienced industry auditors.

Q: How do you see quality management evolving at Optikos in the next years?

NM: There’s always room for improvement as we grow. Systems must be developed alongside company expansion. Honestly, I don’t think we should relax when it comes to quality management. But also, because of our strong foundation, I don’t think we’ll run into something too big for our team. The commitment from the top combined with team-wide ownership gives me a positive outlook.  Keeping up with any news regarding legislation and industry standards as well as continuous improvement will be key for Optikos moving forward.  For the rest, I trust the team at Optikos to continue doing a professional job day-in, day-out.

For Optikos, engineering readiness means every team member lives the quality standard daily, delivering precision optical solutions that withstand both performance demands and regulatory expectations. Find out what our team can do for your project today.

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Meet Us at ADLM 2026

Optikos will be at ADLM 2026 in Anaheim, sharing how our ISO 13485 zero‑finding recertification supports the medical device, diagnostics, and life science teams we partner with. Visit us at Booth #1560 to meet our team and explore how our optical engineering and manufacturing capabilities can support your next innovation. Contact us at sales@optikos.com to set up a meeting in advance.