We are a highly experienced and specialized medical device, IVD and combination product regulatory consultancy supporting healthcare stakeholders from market entry through ongoing lifecycle compliance, ensuring alignment with MDR, IVDR, FDA, and global requirements.
Dr. Bassil Akra, Founder
Manufacturers had at least one certificate delayed/closed due to Clinical/Performance Evaluation MDR deficiencies
Manufacturers required up to four months to update PMS reports under IVDR
and MDR
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We help you navigate the complex world of clinical, regulatory, and quality requirements for medical devices, in vitro diagnostic devices, and combination products.
Comprehensive audits and gap assessments to ensure conformity, risk mitigation, and audit readiness
Learn more about our various service offerings
We support medical device, in-vitro diagnostic, and combination product manufacturers with practical regulatory solutions across the full product lifecycle. Our approach combines deep regulatory expertise with predictable processes and a strong focus on patient safety and compliance.
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Access Expert Guidance When You Need It Most
In the fast-paced world of medical device and diagnostic manufacturing, challenges don’t arrive on a schedule. Our innovative subscription model gives you dedicated consulting hours at your fingertips – ready when you need them, without the stress of unexpected costs.
Our clients trust AKRA TEAM for clear, pragmatic regulatory expertise that supports compliant decision‑making across the entire product lifecycle, from market introduction to ongoing safety and regulatory compliance under MDR, IVDR, FDA and beyond.
We are sincerely grateful for the trust our clients place in us and value the long-term partnerships that make this work meaningful.
We deliver expert‑led regulatory trainings and actively host and participate in professional events to support interactive learning and knowledge exchange across the medical device and IVD sector. Human connection, dialogue, and networking are integral to how we share expertise and build long‑term professional relationships.
We design training programs that address the entire medtech product lifecycle and can be further customized to fit your team’s exact needs
Expert‑led events we host and contribute to, fostering regulatory dialogue, knowledge exchange, and meaningful connection.
Laser-focused webinars offering timely, expert insights to keep medical device and IVD professionals continuously up to date.
Behind every project is a team of seasoned and dedicated professionals, led by Dr. Bassil Akra and our Senior Managing Consultants. Get to know the people who drive the company, and industry forward.
Founder - Executive Consultant
Senior Managing Consultant
Senior Managing Consultant
We support the full spectrum of medical devices, in vitro diagnostic devices, and combination products, ranging from low‑risk to high‑risk and innovative technologies. This scope includes implantable devices, software and AI‑based solutions, novel materials, and borderline technologies.
We provide MDR/IVDR strategy development, technical documentation preparation, gap assessments, performance and clinical evaluation support, post-market surveillance documentation, and readiness consulting for notified body submissions and audits.
Our technical and clinical writing team can prepare and provide end‑to‑end support for CEPs/CERs, risk files, technical documentation, PMS/PMCF plans and reports, PSURs, validation reports, and more – all aligned with the latest standards, regulations, common specifications, and guidance documents.
We can certainly assist with 510(k)s, De Novos, PMAs, and pre‑submission strategies for the US market. Our experts can also support you with your transition to the new Quality Management System Regulations, QMSR, and check your readiness for FDA inspections. We can also support your 21 CFR Part 11 compliance, production controls, UDI implementation, recall strategies, medical device reporting, CAPA Management, internal audits, and more.
Yes, our consultants support manufacturers navigating global regulatory pathways, and we can help your market entry in the UK, Switzerland, Canada, Australia, Asia‑Pacific, and other regions, ensuring alignment with diverse market expectations and evolving requirements.
Absolutely. We provide on‑site and virtual training to teams in the EU, US, and around the world. You are also welcome to bring your team to our offices, and take advantage of our new classroom facilities.
We also offer unique embedded training and mentorship where you can be immersed in an environment that will accelerate your learning. This is a popular service requested by companies that are trying to train new hires quickly, so that they can be brought up to speed with the latest in clinical and regulatory affairs.
Yes, our global team supports clients all over the world, allowing for flexible scheduling and rapid communication.
We conduct comprehensive audits and assessments for ISO 13485, MDR/IVDR readiness, MDSAP, 21 CFR 820, supplier audits, due‑diligence reviews, and technical documentation compliance. We can also include action plans and implementation guidance.
We also perform regulatory and quality due diligence, risk assessments, and pre- and post‑acquisition remediation.
Our subscription model gives you access to on‑demand consulting hours, flexible monthly investments, expert guidance without unexpected costs, recurring regulatory check‑ins, and rapid access to specialists when challenges arise. Subscription clients benefit from priority access, pre‑allocated consulting capacity, and accelerated turnaround times. With an AKRA TEAM subscription, you can skip the contract setup process and any internal purchasing approvals which can delay your access to consulting expertise.
You can book a free 15‑minute consultation or a paid 1‑hour meeting through our Contact page. During this session, we will listen to your needs and match you with the right experts and service package.
Whether you’re launching a new device, preparing for major regulatory changes, positioning your device to expand its intended use or enter a new market, or scaling your quality and clinical affairs infrastructure, AKRA TEAM delivers expert support backed by real-world experience and deep regulatory insight.
Get access to our diverse team. Reach out to us today!
