We support you in planning and executing successful meetings with your Notified Body, helping craft compelling messages and anticipate key questions to maximize outcomes.
Medical Devices Development Consulting
Accelerate your path to market with expert-driven development strategies.
At AZB Consulting, we combine deep regulatory intelligence with the proven expertise of our consultants to drive the success of your Medical Device development programs. With extensive experience working with notified bodies and national regulatory authorities, we anticipate challenges and help you navigate the path to CE marking with confidence.
From the marketing brief to commercialization, we offer end-to-end strategic and operational support tailored to your product and strategy. Our experts ensure your development aligns with evolving guidelines to build solid foundation for the writing of the technical documentation according to current requirments.
Whether entering Europe for the first time or expanding your footprint, we provide a clear, customized roadmap through EU and National regulatory pathways – helping you reach the market faster and more efficiently.
Our services include regulatory strategy, submission planning &, support with your notified body, risk assessments, gap analysis and due diligence. We provide advice to ensure you’re always one step ahead of regulatory expectations.
Medical Devices Development Consulting
Accelerate your path to market with expert-driven development strategies.
At AZB Consulting, we combine deep regulatory intelligence with the proven expertise of our consultants to drive the success of your Medical Device development programs. With extensive experience working with notified bodies and national regulatory authorities, we anticipate challenges and help you navigate the path to CE marking with confidence.
From the marketing brief to commercialization, we offer end-to-end strategic and operational support tailored to your product and strategy. Our experts ensure your development aligns with evolving guidelines to build solid foundation for the writing of the technical documentation according to current requirments.
Whether entering Europe for the first time or expanding your footprint, we provide a clear, customized roadmap through EU and National regulatory pathways – helping you reach the market faster and more efficiently.
Our services include regulatory strategy, submission planning &, support with your notified body, risk assessments, gap analysis and due diligence. We provide advice to ensure you’re always one step ahead of regulatory expectations.
Our Expertise
At AZB Consulting, we offer a comprehensive suite of regulatory services designed to accelerate drug development and ensure compliance at every stage. Our team provides strategic, scientific, and operational support across key areas:
Development of products
We design development strategies that are scientifically acceptable, compliant, and aligned with your development timelines and global regulatory requirements. We support your company to find manufacturing plants and raw material suppliers according to your needs, quality and regulatory requirements.
Regulatory Strategy & Roadmap
We develop tailored regulatory strategies and roadmaps aligned with your product lifecycle and business goals -guiding you efficiently from the marketing briefing document to the CE Marking.
Biological Evaluation, Clinical Evaluation, Risk Management, GSPR, Usability, Design & Manufacturing are our proposed Solutions
We provide strategic input and documentation support to ensure your technical documentation meet EU and global regulatory requirements.
Notified Bodies Meetings and audits
Due Diligence
We offer full support for Due Diligence of your dossiers to evaluate potential gaps, associated risks and anticipate questions from Notified Bodies.
Gap Analysis
Our comprehensive gap analysis and regulatory gap analysis assessments help you identify potential risks, validate readiness, and make confident development or investment decisions