Consulting & Technology
We support you through a combination of scientific excellence, technological expertise, cross-sector consulting know-how and practical implementation.
In this way, we create measurable added value and drive sustainable business success.
- Scientific excellence and technological expertise
- Cross-sector consulting expertise
- Practical implementation with measurable added value
This is how sustainable business success is achieved — data-based, future-oriented and strategically grounded.
Assistance with standards interpretation, gap analyses and audit preparation. Through a clearly defined CE approval strategy, we create regulatory security and combine technical requirements with economic goals.
Through failure analysis, lifetime assessments and safety assessments, we identify and assess technical risks at an early stage. This creates a sound basis for decision-making for development, production and management.
We assist you in the development of test concepts, the definition of efficient testing strategies and in structured documentation. The aim is a sustainable increase in quality, efficiency and process reliability.
Through feasibility analyses, early test planning and technical second opinions, we provide structured support for innovations, minimizing risks and accelerating development.
Overview of benefits
What makes us special: our advice is based on on operational experience rather than theoretical interpretation of standards. As a testing laboratory for electromagnetic compatibility and as a strictly regulated manufacturer of pharmaceuticals, regulatory requirements, audit situations and approval processes are part of our DNA.
Our strength lies in a combination of technical testing, regulatory understanding and strategic implementation. This makes for for reliable decisions, secure products and sustainable market access.
Lean Compliance
Lean compliance means implementing regulatory requirements such as ISO 17025 or GMP in such a way that only value-adding and necessary process steps remain in place. The aim is to avoid bureaucracy, duplication and media breaks (PapierèExcel) without jeopardizing legal certainty.
A Laboratory Information Management System (LIMS) digitizes and centralizes all relevant laboratory processes. This system manages samples, controls test processes, collects measurement data and creates reports automatically. This results in a significant reduction of manual data entries and transmission errors. The administrative workload per sample is typically reduced by 30%, resulting in faster reporting, lower error rates and personnel savings. The combination of lean compliance and LIMS sustainably increases efficiency, transparency and scalability while improving regulatory security.
QA turnaround
QA turnaround describes the targeted stabilization, restructuring and optimization of a quality assurance system in order to restore compliance, efficiency and auditability quickly and sustainably.
We ensure the quality of your quality assurance systems
Quality management systems grow together with companies. In the process, they often become complex, cumbersome or no longer compliant with standards. An effective QA turnaround means specifically stabilizing, further developing and efficiently realigning your QM system.
We support your QM system all the way from introduction, testing and optimization to structured adjustment or necessary streamlining.
Our range of services includes:
- Support in setting up a QM system in accordance with standards
- Conducting internal audits to prepare for external audits
- Adapting and expanding existing systems to meet new regulatory requirements
- Identification of inefficiencies and reduction of “gold plating” to sustainably increase efficiency
Our expertise is based on over 25 years of accredited practice as a testing, calibration and verification body as well as on GLP and GMP approvals. In addition, we have certifications including ISO 27001, ISO 29993 as well as international approvals from WADA, CTBTO and the KBA.
Our experts are regularly employed as technical experts in audits by the state accreditation body — a quality standard that is directly reflected in our advice.
QA turnaround with substance: standards-compliant, audit-proof and operationally effective.
Process management
From the design phase through implementation to successful certification and continuous optimization of your processes — in us, you gain a partner who combines scientific expertise, regulatory know-how and practice-oriented solutions. This offer is aimed at companies in pharmaceutical, chemical, medical technology, radiopharmaceuticals, analytics and related industries who want to ensure the highest quality and safety.
Our interdisciplinary team offers you practical and regulatory-compliant advice so that you can achieve the highest standards in your organization and ensure them sustainably:
- Support in setting up, validating and optimizing quality management systems
- Carrying out internal and external audits in accordance with ISO, GMP and GLP
- Adapting QM systems to new regulatory requirements
- Digitalization of existing QM systems and integration of modern documentation solutions
- Advising verification centers, calibration centers and test centers
- Implementation of information security management systems (ISMS) in accordance with ISO 27001
- Tailored QM trainings and training programs
Cyber Resilience Act
With the Cyber Resilience Act (CRA), the EU is creating binding cybersecurity requirements for products with digital elements for the first time. Manufacturers, importers and distributors are required to demonstrably meet safety requirements across the entire product life cycle. Lack of compliance can result in market restrictions, liability risks, and significant damage to your reputation.
Especially for hardware and connected devices, the regulatory requirements for secure product architectures, vulnerability management and technical documentation are increasing significantly.
Our range of services
Support for the standard-compliant and practical implementation of CRA requirements:
- Regulatory impact analysis and risk classification
- Technical security assessments of hardware and embedded systems
- Review of security-by-design and security-by-default concepts
- Evaluation of update, patch, and vulnerability management processes
- Gap analyses of existing products and development processes
- Assistance with technical documentation and proof of conformity
With our combination of technical testing depth and regulatory expertise, we support you from the initial analysis to a reliable declaration of conformity.
Zoning
In safety-relevant areas such as meeting or situation centers, there is a risk of electromagnetic radiation transmitting confidential information to the outside world. Inadequate shielding can lead to information leakage and security breaches.
Review and validation of protected areas in terms of their zoning concepts is necessary to ensure that shielding measures are effective and that defined protection goals are achieved. The metrological proof of shielding attenuation creates a reliable basis for the safe operation of sensitive areas.
training
Our practice-oriented training provides the technical and organizational principles for structured incident response. The AIT Cyber Range simulates realistic cyber attacks. Participants analyze security incidents using IDS and SIEM tools, create situation images and make coordinated technical and management-related decisions.
You have an idea...
We will holistically evaluate and analyze the feasibility of your idea, including both technical and economic framework conditions. In doing so, we identify potential critical issues at an early stage in order to make risks transparent and create a well-founded basis for decision-making. This is the beginning of a structured and realistic roadmap that defines clear milestones and next steps. At the same time, we clarify the relevant regulatory framework and ensure that these are taken into account during implementation. Thanks to our established network, we find suitable partners to develop, implement and scale your idea.
You need a prototype...
Together with you, we develop a tailor-made demonstrator or prototype for you that makes your vision tangible and realistically depicts central functions. Its capabilities and performance characteristics are then systematically evaluated in order to transparently present strengths, limits and possible uses. On this solid basis, we design a market-oriented Minimum Viable Product (MVP) for you that combines the greatest possible added value with efficient use of resources. The targeted identification of optimization potential creates the basis for sustainable development and the scaling of your innovation.
You want to bolster your innovative strength...
The “Innovation Studios on Tour”: we organize a workshop for you in which we promote imagination, creativity and ingenuity, challenging and providing impulses for innovation through guided thought experiments.
You want to establish an innovation process...
We implement our successful model, tailored to your requirements, and implement a sustainable solution with our software partner. In this way, we ensure that no ideas are lost to your company and that the potential for successful innovations is exploited.
Technical due diligence
Investment decisions are often based on market potential, business models and growth prospects. However, there is a decisive phase between a functioning prototype and a production-ready product, the complexity of which is often underestimated.
The step from demonstrator to market readiness entails technical, regulatory and production risks. Overlooked details can postpone schedules, change cost structures or, in the worst case, jeopardize the entire business model.
We create a reliable basis for decision-making as part of our technical due diligence. This includes:
- Comprehensive testing of functionality and performance
- Identification of technical weaknesses and development risks
- Product life cycle and scalability assessment
- Analysis of applicable standards, guidelines and regulatory requirements
- Identification of critical components, dependencies, and supply chain risks
Our expertise is based on decades of experience in demanding development projects, including satellite-compatible measurement systems, industrial automation, high-precision quality assurance and applications critical for safety.
As an independent, objective institution, we combine technical depth with regulatory understanding and practical implementation expertise. In this way, we create transparency, minimize investment risks and enable well-founded decisions for investors, companies and strategic partners.
Implementing innovation
We support you all the way from the initial idea, through development, and on to a successful market launch and the sustainable scaling of your company. With us, you gain a partner who combines scientific excellence, regulatory expertise and practice-oriented innovation strategies. We create clarity and transparency in complex processes, reduce risks and open up new growth opportunities. This offer is aimed at start-ups, technology-oriented companies and established industrial companies that want to ensure innovation, quality and competitiveness in the long term.
Our services
- Testing the functionality, performance, and technological maturity of your products
- Identification of weak points throughout development, implementation and supply chain
- Assessment of life cycle, scalability and the market situation and existing competitors
- Clarification of applicable standards, regulatory requirements and regulatory risks
- Development of strategies for risk minimization and sustainable positioning
- Optimizing development processes, organizational structures and efficiency
- Support of innovation projects from idea to market launch
- Evaluation of business models, financing options and investment capacity
- Preparation of technology roadmaps and identification of trends and disruptive technologies
- Creating transparency through objective analyses and second opinions, laying the groundwork for well-founded decision making
Reports & expertises
Seibersdorf Laboratories offers a comprehensive portfolio of consulting, expert and expertise-based services that address technical, regulatory and safety-related issues for companies, authorities and research institutions.
Electromagnetic compatibility (research & technical consulting, EMC)
