Samaras Associates Inc

FDA regulatory and safety engineering consultants for medical devices

Est. 1997

1-10 employees

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Verified

29+ Yrs

5 Certs

About Samaras Associates Inc

Samaras Associates Inc is a healthcare engineering consultancy established in 1997, specializing in medical device development and health information systems. The firm operates as a private practice focused on regulatory compliance, risk management, and safety-critical system design for medical devices ranging from Class 1 accessories to untried Class 3 devices.

The company provides comprehensive support across the medical device development lifecycle, including FDA regulatory assistance with 510(k) submissions, IDEs, and PMAs; ISO 13485-compliant quality management system implementation; ISO 14971 risk analysis; IEC 62304/62366-compliant software and human factors engineering; and mechatronic device design and validation. Both principals are professional members of the American Society of Safety Professionals and offer personalized service to clients ranging from global multinationals to startups.

Samaras Associates has served both domestic and international clients for over 25 years, with additional experience as expert witnesses in medical device product liability litigation. The firm emphasizes structured, systematic, and well-documented product development processes as the foundation for regulatory compliance and product safety.

Best For

Medical device manufacturers and health IT companies seeking specialized regulatory compliance and safety engineering expertise. Particularly well-suited for organizations developing Class 2 or Class 3 medical devices requiring FDA submissions, companies implementing quality management systems, and firms developing safety-critical mechatronic medical devices that require rigorous risk management and human factors validation.

Key Strengths

27 years of specialized experience in medical device regulatory compliance and FDA submissions across all device classes
Both principals are professional members of the American Society of Safety Professionals with expertise in safety-critical systems
Comprehensive expertise spanning regulatory affairs, quality systems, risk management, human factors, and mechatronics in a single practice
Expert witness experience in medical device product liability litigation demonstrating deep regulatory and safety knowledge
Personalized service model with direct access to principals rather than junior staff
Experience serving both global multinationals and startups with tailored approaches

Why Choose Samaras Associates Inc

Choose Samaras Associates when you need deep regulatory and safety engineering expertise delivered through a personalized consultancy model. The firm excels in complex FDA regulatory pathways, risk management for high-risk devices, and situations requiring comprehensive understanding of the intersection between regulatory compliance, quality systems, and engineering design.

Expect hands-on engagement from experienced principals who bring both technical engineering expertise and regulatory knowledge. The practice is particularly valuable for companies navigating their first FDA submission, implementing quality systems, or developing safety-critical devices where comprehensive risk analysis is essential.

Healthcare Focus

Samaras Associates exclusively serves the medical device and health information systems sectors, with 100% focus on healthcare. The firm's expertise centers on FDA regulatory compliance pathways (510(k), IDE, PMA), Quality System Regulations, and international standards specific to medical devices (ISO 13485, ISO 14971, IEC 62304, IEC 62366).

Their healthcare specialization extends from medical device accessories through the highest-risk implantable devices, with particular expertise in safety-critical systems where device failures could result in patient harm. This includes both hardware medical devices and software as a medical device (SaMD), with comprehensive understanding of the regulatory frameworks governing both.

Ideal Client Profile

Medical device companies developing Class 2 or Class 3 devices requiring FDA clearance or approval, particularly those with mechatronic components or safety-critical functions. Organizations implementing or improving quality management systems to meet FDA QSR or ISO 13485 requirements. Startups transitioning from prototype to commercial medical device production who need comprehensive regulatory and engineering guidance throughout the development lifecycle.

Specializations

FDA 510(k) regulatory submissions ISO 14971 risk management Medical device human factors engineering IEC 62304 software validation Quality management system implementation Safety-critical medical device development Mechatronic medical device design