FDA SaMD Consulting & Development Services

FDA SaMD Consulting and Development Services combine regulatory consulting with software engineering to help organizations bring Software as a Medical Device (SaMD) products to market. These services typically include product classification, regulatory strategy, FDA submissions, compliant software development, verification and validation, and post-market support.

The appropriate pathway depends on your product's intended use, risk classification, and whether a legally marketed predicate device exists.
‍510(k): For products substantially equivalent to an existing device.
‍De Novo: For novel, low-to-moderate risk devices without a predicate.
‍PMA: For high-risk devices requiring extensive clinical evidence.
Selecting the right pathway early can significantly reduce regulatory delays.

Avoiding an RTA begins with a well-prepared submission. Complete technical documentation, clear intended use statements, appropriate predicate analysis, cybersecurity documentation, software lifecycle evidence, and thorough verification and validation all contribute to a submission that satisfies FDA acceptance criteria.

Regulatory responsibilities continue after clearance. Organizations must manage software updates, cybersecurity, post-market surveillance, complaint handling, quality management, and regulatory assessments for future product changes to maintain ongoing compliance.

Software is generally considered SaMD if it performs a medical function without being part of a physical medical device. Determining whether your software qualifies depends on its intended use, clinical claims, and risk profile. A regulatory assessment helps establish the appropriate classification before development begins.

A predicate device is a legally marketed medical device used to demonstrate substantial equivalence during a 510(k) submission. Identifying an appropriate predicate helps establish the regulatory pathway and defines much of the supporting evidence required by the FDA.

The FDA expects AI-enabled SaMD products to demonstrate safety, effectiveness, transparency, and ongoing lifecycle management. Organizations developing adaptive AI solutions should also prepare Predetermined Change Control Plans (PCCPs), model monitoring strategies, validation evidence, and documentation that supports future algorithm updates.

Pricing depends on the scope of regulatory consulting, submission complexity, software development requirements, AI capabilities, verification and validation activities, and post-market support. Organizations can engage Zymr for regulatory strategy, engineering, submission support, or an end-to-end delivery model through our Global Capability Center (GCC).