Anita Dalrymple,

Principal Consultant

Passionate SME, guiding medical device development through regulatory strategy & compliance, risk management, and an integrated engineering/clinical view of safety and efficacy/performance.

I have enjoyed opportunities to work in many aspects of medical device development. Besides compiling, writing, and filing 510(k)s, Technical Files, CERs, and other regulatory submissions, I've worked closely with engineering teams on design input requirements, design verification and validation protocols and reports, other risk management activities including FMEAs, pilot study DOEs, and marketing aspects of medical devices such as labels and labeling.

Medical Device Regulatory Inc.

Regulatory Affairs & Quality Contract Services

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