Regulation, Patient Safety, Clinical Application

Medicine & Pharmaceuticals

Reliable testing, in-depth analysis and regulatory compliance for medical devices and pharmaceutical applications. Radiation protection for medical staff and patients.

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Medicine & Pharmaceuticals

Typical Requirements of our Customers

In the medical and pharmaceutical sectors, quality, safety and regulatory compliance are crucial. We support you with accredited testing, analytical expertise and many years of experience – from development through to regulatory approval and safe operation.

Our services combine scientific precision with a practical understanding of regulatory requirements and clinical applications.

Typical requirements include, among others:

  • Compliance with regulatory requirements (GMP, authorisation, standards) 
  • Patient safety and efficacy 
  • Validated testing and measurement procedures
  • Safe handling of radiation and sensitive technologies 
  • Complete documentation and quality assurance 
Medicine & Pharmaceuticals

Overview of Services

Radiation Protection, Dosimetry and Measurement Services

We support medical facilities and manufacturers in the safe handling of ionising and non-ionising radiation.

  • Personal dosimetry & dose monitoring
  • Digital document management in the ePortal
  • Radiation protection & exposure assessment
  • Laser, LED & Lamp Safety

More on radiation protection

About laser, LED & lamp safety

Radiochemistry and Specialised Analysis

We offer specialised analysis and assessment for applications involving radioactive materials.

  • Radiochemical analyses
  • Analysis of radioactive materials

More about radiochemistry

Calibration and Metrological Verification

Precise measurements are the foundation of safe medical applications.

  • Verification and calibration
  • Validation of measurement systems

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Expert Reports and Regulatory Support

We assist you with safety assessments and approval processes.

  • Radiation protection reports
  • Laser safety reports
  • Medical physics
  • Type approvals
  • Safety assessments

More about Consulting

Management of Radioactive Waste in the Medical Sector

We support medical facilities in the safe assessment and clearance of materials related to radioactive applications.

  • Measurement and clearance procedures for potentially contaminated waste
  • Use of portal monitors (e.g. to monitor waste streams in hospitals)
  • Support with regulatory requirements and clearance processes
  • Assessment and documentation of contamination

more on waste disposal

Medical Training and Continuing Education

We provide practical knowledge for the safe operation of medical systems.

  • Radiation protection courses
  • Laser safety courses
  • Subject-specific training

About the Seibersdorf Academy

 

The Benefits for You

You receive standards-compliant, validated results that serve as the basis for regulatory approval, quality assurance, and the safe use of your products and applications.

When we can help you

Typical Challenges in Healthcare & Pharmaceuticals

Our specialized industry solutions for healthcare and pharmaceuticals support companies across the entire value chain—from research and development through production to regulatory approval and distribution. With deep industry knowledge, regulatory expertise (e.g., GMP, MDR, FDA), and modern digital solutions, we optimize processes, enhance compliance, and accelerate time-to-market. With a regional presence and an international focus, we support pharmaceutical companies, medical device manufacturers, and healthcare providers in their digital transformation, automation, and quality assurance. Efficient, secure, and forward-looking - for sustainable success in the healthcare market.

Typical applications include, among others

  • Development and approval of medical devices
  • Manufacturing and quality assurance of pharmaceutical products
  • Operation of medical facilities that use radiation
  • Protection of electromagnetically sensitive equipment
  • Preparation for audits and regulatory inspections

Contact us – we’d be happy to assist you.

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