Regulatory Compliance

Ensuring full compliance with industry standards and regulations

AZ Biotech Consulting supports clients in achieving and maintaining compliance throughout the entire product lifecycle — from design and development to market access and post-market surveillance.
Our expertise spans European and international regulations, including the MDR, IVDR, and relevant standards such as ISO 13485, ISO 14971, and IEC 62304.
We assist with technical documentation preparation, CE marking strategy, device classification, performance validation, and regulatory submissions, ensuring products meet the highest standards of safety, efficacy, and quality.

Quality Management

Implementing robust systems for quality assurance

We design, implement, and optimize Quality Management Systems (QMS) tailored to each company’s size, structure, and objectives.
Our services include:

  • Development of quality documentation (procedures, records, risk matrices);
  • Support for ISO 13485 certification;
  • Management of internal and external audits;
  • Staff training on quality and regulatory requirements.

Our goal is to build a flexible, efficient, and compliant quality system that drives both performance and trust.

Strategic Consulting

Providing insights and strategies for business growth and innovation

AZ Biotech Consulting helps companies define and execute their regulatory and operational strategies.
We provide expert guidance for key decision points such as:

  • Assessing regulatory feasibility of new products;
  • Planning market access and certification pathways;
  • Structuring partnerships and R&D collaborations;
  • Strengthening quality and regulatory governance.

Our strategic approach combines scientific understanding with regulatory insight and business vision — ensuring sustainable growth and successful innovation.

Start-up Support

Helping innovative companies build a strong foundation for success

We offer tailored support for start-ups in the biotechnology, diagnostic, and medical device sectors — from early development to market launch.
Our assistance covers:

  • Early-stage regulatory and quality strategy;
  • Preparation of technical documentation and validation plans;
  • Mentorship for founders and R&D teams;
  • Guidance for investor readiness and due diligence.

With our experience, start-ups can navigate complex regulatory pathways while focusing on innovation and market impact.

Software Development Expertise

Guiding companies through the regulatory requirements of medical device software

As specialists in Software as a Medical Device (SaMD) and embedded medical software, we support developers and manufacturers through every phase of design, verification, validation, and certification.
Our expertise includes:

  • Compliance with IEC 62304 (software lifecycle processes);
  • Risk management according to ISO 14971;
  • Preparation of the technical documentation;
  • Verification and validation activities;
  • CE marking preparation and support.

AZ Biotech Consulting enables clients to transform innovative software concepts into safe, compliant, and market-ready medical products.

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