Optimum Technologies Offers Enhanced Regulatory Services

Since 1994, Optimum Technologies, Inc. has provided world-class product development services to our clients, with a focus on optics-based medical devices. We are now pleased to announce that we have recently expanded our regulatory group to better serve our medical device clients.

joe curtis regulatory compliance“Our newest offering encompasses
regulatory strategy development,
as well as full implementation
of those strategies.”

Joe Curtis, Director of Regulatory Affairs
and Quality Assurance

Our areas of expertise include:

Overall Regulatory Strategy

Early in the business formation process, a regulatory strategy should be developed to ensure successful entry into the medical device space. It’s crucial to keep the following points in mind:

  • Not every product is launched in the USA first. Sometimes, it makes sense to consider the EU or other markets for initial launch.
  • The Notified Body you partner with can have a significant impact on your company’s credibility and valuation. Our team can guide you through the selection process, and interface with leading Notified Bodies.
  • Achieving certification for the medical device design control standard ISO 13485, as well as compliance with the risk management standard 14971 can also have a big impact on how your company is perceived and valued. We can help determine if and how these goals should be met, and provide the resources to help you get there.

Specific Device Strategy

Any development plan for a specific device must include its regulatory path. Our team can support you as you plan and implement your regulatory strategy for a specific device in the US, Europe, and other markets, including:

  • Identifying your device classification and finding regulatory predicates in each market
  • Establishing a regulatory strategy for your specific device in each market
  • Supporting your regulatory submissions in the US: No-510(k), 510(k), IDE or PMA
  • Supporting the Technical File and Design Dossier in compliance with the Medical Device Directive (MDD — Europe)
  • Strategizing for clinical usage of your device in each market, either pre- or post- approval(s)

Highly trained Professionals with Years of Experience in the Regulatory Space

Our regulatory group is led by Joe Curtis Director of RA/QA. Joe has decades of expertise in Regulatory and Quality management.

His experience runs the gamut from original Pre-Market Approval (PMA) with the US FDA on an implantable cardiac device to establishing ISO 13485-compliant Quality Management Systems for a number of medical device startups.

Prior to his 30+ years of RA/ QA experience within the medical device arena, Joe was an interventional radiologic technologist who bought and used medical devices.

The bottom line: Optimum has the technical expertise and proven process knowledge that helps our clients achieve their fundable milestones—every time.