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We are proud to bring together professionals who share a commitment to integrity, excellence, and meaningful results. Their dedication to advancing the industry is what truly sets our team apart.
AKRA TEAM is the a trusted global partner for medical device, in vitro diagnostic (IVD), and combination product compliance. We support manufacturers, authorized representatives, and other stakeholders around the world with strategic regulatory, quality, and clinical expertise designed to accelerate market access and ensure long term success.
Expert guidance for EU MDR, IVDR, FDA, and global markets — tailored regulatory strategies to navigate complex approval pathways.
Professional writing of technical files, clinical evaluations, and regulatory submissions crafted to meet the highest compliance standards.
Customised remote and in-person training sessions with tailored mentorship — empowering your team with regulatory knowledge and confidence.
Comprehensive audits and gap analyses to identify compliance risks and prepare your organisation for successful regulatory submissions and market access.
Specialist support for innovative, complex, and high-risk devices — navigating the unique regulatory challenges that cutting-edge technologies present.
Ready-to-use, expertly crafted templates for key clinical, regulatory, and quality documents — saving time and ensuring consistency across your submissions.
Navigating the world of regulatory requirements can be challenging. As your trusted partner, AKRA TEAM will dedicate our knowledgeable team to help you understand the latest in global standards, regional laws, as well as the latest guidance and current best practices, ensuring your team stays aligned, prepared, and competitive.
Full-scope strategies for medical devices, IVDs, and combination products across all major regulatory frameworks and global markets.
Our team has guided hundreds of successful submissions and product registrations — bringing deep, practical experience to every engagement.
Hands-on guidance for borderline classification, SaMD, AI/ML-incorporated devices, and other innovative or high-risk technologies.
Extensive experience managing submissions and direct communication with regulatory authorities on behalf of organisations worldwide.
Clear, compliant, and audit-ready documentation is essential for regulatory success. Our writing specialists create high-quality submissions aligned with notified body and regulator expectations, country-specific requirements, international standards, and applicable guidelines.
Strengthen your internal capabilities with training designed for teams working in regulatory, quality, and clinical affairs. We provide training anywhere in the world — EU, North America, Asia, and beyond — or opt for remote training using virtual tools to connect with our experts.
Prepare for notified body assessments, FDA reviews, MDSAP audits, or internal compliance checks with comprehensive, expert-led evaluations. We provide action plans with extended implementation support, ensuring you cross the finish line into new markets.
When critical decisions are on the line, perceptions and
A lean process or quality management system can enable your organization to be scalable, more efficient, and more capable of achieving its goals. AKRA TEAM helps you simplify processes, reduce complexity, and improve efficiency, all while maintaining full alignment with regulatory and quality requirements.
High‑Quality, Audit‑Ready Templates Trusted by Medical Device & IVD Manufacturers Worldwide
Regulatory documentation doesn’t have to slow you down.
AKRA TEAM’s template library provides professionally written, regulator‑aligned documents designed to streamline your submission process, reduce errors, and accelerate market access.
Developed by senior consultants with decades of experience in EU MDR, IVDR, and global regulatory pathways, these templates give your team the clarity, structure, and precision needed to build compliant, inspection‑ready documentation with confidence.
Clinical Evaluation Report frameworks aligned with MDCG guidance
Post-market surveillance and follow-up plan templates
ISO 14971-aligned risk file templates and risk matrices
MDR / IVDR technical documentation structure and content guides
Every organization’s needs are different, so we’ve designed two complementary ways for you to partner with AKRA TEAM, giving you the freedom to choose the model that best supports your goals, timelines, and unique requirements.
Learn more about our service models and how we partner with you