Regulatory Strategy and Submission - Medical Device
Medical Device Regulatory Affairs Built for the Complexity of Modern Device Development
The road from prototype to approved device is rarely straightforward. Regulatory pathways shift, standards evolve, and the margin for error in submissions is slim. At AAPS Pharma, we bring the strategic clarity and hands-on regulatory experience your team needs to move forward with confidence—whether you’re filing a first-in-class SaMD, navigating EU MDR transition requirements, or preparing for an FDA inspection.
Device Expertise Across Every Class
We understand that no two device programs are the same, and we don’t treat them that way. Each engagement is built around your product’s specific classification, intended use, and target markets—so the strategy we develop is grounded in the real requirements you face, not a generic checklist.
Your Partner Through High-Stakes Moments
Regulatory submissions, quality system overhauls, inspection readiness—these are the moments where the right guidance makes all the difference. We work alongside your team as a true partner, not just a document vendor, ensuring that every filing is accurate, every gap is addressed, and every deadline is met. When the stakes are high, AAPS Pharma is the team you want in your corner.
Our Services
Whether you’re a hardware, SaMD or IVD company, from Class I to III, let AAPS Pharma help create a
winning strategy and navigate high-stake situations such as device filings, and quality and compliance
hurdles.
- 510(k), De Novo and PMA submissions, including PMA Supplements
- EU MDR/IVDR and CE marking
- ISO 13485, ISO 14971, IEC62304
- Health Canada Class 2, 3 and 4 medical device licensing
- Companion Diagnostic 510(k) and PMA submissions
- IDE submissions
- Regulatory compliance with key standards like ISO 13485 and FDA 21 CFR 820
- MDSAP
- Risk management, including hazard analysis, FMECA and FTA support
- QMS building, gap analysis, and support
- Internal audits and audit readiness
Medical Writing
Precise, clear clinical and regulatory writing: protocols, CSRs, IND content, safety updates, patient-facing materials.
Regulatory Submissions-(Bio)Pharma
Strategy and execution for global filings: CTD/eCTD support, agency readiness, and lifecycle compliance.
Regulatory Submissions-Medical Device
Global regulatory support across hardware, SaMD, IVD and combination products, covering audit readiness, MDSAP, and US/EU submission pathways.
Quality & Compliance
QMS build and remediation support: SOPs, change control, CAPA/deviations, OOS, stability and audit readiness.
What Can We Help You With?
Interested in AAPS Pharma? Take the first step by reaching out to us directly or simply drop your details below for a personalized call back.
