Successfully certifying Software as a Medical Device (SaMD) requires deep knowledge of both software engineering, medicine and regulatory expectations. At Pharmaxi, we help our clients navigate the entire certification process efficiently, with support tailored to each development phase. Below is a summary of what we offer to help bring your SaMD to market:
Gap Analysis of Your Documentation and Processes
We begin by reviewing your current technical documentation, development lifecycle artifacts, and risk management procedures. Our gap analysis identifies where your software and supporting evidence may fall short of regulatory requirements such as IEC 62304, ISO 13485, and EU MDR — giving you a clear roadmap for remediation.
Pre-Submission Readiness Review
Before submitting your package to regulatory authorities, it is critical to ensure that every detail is complete and compliant. Our pre-submission readiness review helps you avoid costly delays and surprises by identifying any remaining gaps early.
We provide clear recommendations on how to resolve compliance issues and assist in preparing all necessary documents typically required by notified bodies. By addressing potential concerns in advance, you gain a smoother path to approval and significantly reduce the waiting time that would otherwise occur when comments come back from regulators.
The result: faster approvals, fewer setbacks, and confidence that your submission is fully prepared.
If you have already submitted your documentation package for MDR certification and received questions from a notified body, we can help you navigate the next steps with confidence.
Our experts will carefully review the feedback, identify the root of the issues, and design the most efficient strategy to address them. We will guide you in preparing clear, compliant responses and supporting documents that meet regulatory expectations.
The benefit: you minimize back-and-forth with the notified body, accelerate the review process, and strengthen the likelihood of a successful certification outcome.
Whether it’s an initial Q-sub meeting with the FDA, a consultation with an EU notified body, or communication with the UK’s MHRA, we provide strategic guidance to help you prepare the right documentation and approach for successful interactions.
You can rely on our expertise at any stage of medical device development—during early development, while compiling technical or risk documentation, before clinical data collection, or in the final stages prior to submission.
Our team shares proven experience to help you avoid unnecessary burdens during testing, development, and clinical validation. We also guide you in identifying which type of consultation is available and most effective in each case, ensuring you maximize the value of every interaction with regulators.
The result: clear strategy, stronger submissions, and smoother communication with authorities at every phase of your project.
Validation of Software According to IEC 62304 and GAMP5
Our team helps you build a traceable, standards-compliant validation approach that fits both agile and traditional SDLCs. We ensure your risk assessments, software hazard analyses, test protocols, and reports meet the expectations outlined in GAMP5 and IEC 62304.
Preparation of ISO 13485-Compliant Documents
We assist in aligning your development practices with ISO 13485 by supporting creation or refinement of SOPs, design history files (DHF), software development plans, and validation protocols. Our documentation is audit-ready and traceable.
Clinical Data Collection and Curation
With our deep expertise in clinical trials and medical research, we provide a cost-effective and scientifically robust approach to collecting and curating clinical data directly from patients.
Our services cover a wide range of clinically relevant datasets, including:
These high-quality datasets are carefully curated to ensure reliability and regulatory compliance. They can be leveraged for algorithm development and training, retrospective performance evaluation, and clinical validation studies.
By combining our clinical trial experience with rigorous data management practices, we help you generate the evidence needed to bring safe, effective, and data-driven medical innovations to market.
We offer a cost-effective, medically sound approach to collecting clinical data from actual patients. This includes:
We guide your product through its classification, conformity assessment, and certification journey. Whether your SaMD requires CE marking under Rule 11 of EU MDR or goes through the FDA’s De Novo pathway, we’ll help you select the right route and prepare the full technical documentation package.
✔ Avoid Delays and Rejections
Our unique combination of medical, software, and regulatory expertise helps you sidestep common pitfalls that cause extended review timelines or outright rejections.
✔ Eliminate Redundant Iterations
We align your documentation and test evidence with regulator expectations from the very beginning—saving you from costly rounds of rework.
✔ Optimize Your Launch Timeline
With streamlined, standards-aligned processes, we help you move from development to market faster and with greater confidence.
✔ Reduce Costs
By accelerating submission success and minimizing inefficiencies, we lower your overhead and maximize return on investment.
Bringing Software as a Medical Device to market is complex—but with the right partner, it doesn’t have to be overwhelming.
Whether you’re aiming for CE marking, FDA clearance, or other market approvals, our expert regulatory team is here to guide you every step of the way.
👉 Book your free 30-minute consultation today.
We’ll help you shape the optimal regulatory strategy, streamline your technical documentation, and ensure your validation and clinical evidence meet the highest standards—so you can reach the market faster and with confidence.
