How does Qudits support life-sciences companies?

Qudits supports medtech and pharma companies across the full regulatory spectrum — from MDR-compliant product development, ISO 13485 quality management and SaMD validation to GxP compliance, Computer System Validation to GAMP 5, data integrity to ALCOA+ and the privacy-compliant introduction of AI.

Is Qudits familiar with MDR, ISO 13485 and GxP?

Yes. Qudits has solid regulatory expertise in MDR, ISO 13485, IEC 62304 as well as 21 CFR Part 11, EU Annex 11 and GAMP 5 — and helps lean teams without a large corporate QA department meet regulatory requirements efficiently and audit-ready.

What does GxP-compliant IT mean at Qudits?

GxP-compliant IT means validated systems, complete audit trails and compliance-ready documentation per FDA 21 CFR Part 11 and EU GMP. Qudits performs validations and prepares companies audit-ready for authority and Notified Body inspections.

Can AI be used in a regulated life-sciences environment?

Yes. Qudits runs AI exclusively on EU and Swiss servers with a zero-retention guarantee — preserving validatability, traceability and data protection, with a first pilot productive within a few weeks given a clear use case.

Life Sciences

You change lives. We simplify your processes.

The focus of life sciences is shifting ever more from pharmaceuticals and medical devices toward patients, modern solutions and services. Analysing clinical data, current therapeutic findings and real-time data offers enormous potential — but also raises new and complex questions.

Life-sciences laboratory with cleanroom and analytical equipment

The major challenge in life sciences lies in ever-shorter time-to-market cycles coupled with rising resource demands for research and development. Added to this are the sector's specific regulatory requirements. This creates a tension between innovation and regulatory compliance.

We focus on technologies and digital transformation processes so that you can concentrate on improving patients' lives. To help you bring innovative products and services to market in a compliant way, we develop strategies for end-to-end supply chains and support you through implementation to lasting anchoring within your organisation.

Our experts combine expertise in modern technologies with specific industry experience in pharmaceuticals, biochemistry, medical technology, medical informatics, healthcare and other life-sciences fields.

The Life-Sciences Industry in Transition

1,400+

medtech companies in Switzerland

CHF 50+

billion in Swiss pharmaceutical exports annually

2028

MDR transition deadline for all Class IIb products

21 CFR

Part 11 & EU Annex 11 — compliance standards for electronic records

Sources: Swiss Medtech · Interpharma · Swissmedic

The Challenge

Between MDR 2017/745, ISO 13485 and IEC 62304 on the medtech side, and 21 CFR Part 11, EU Annex 11 and ALCOA+ on the pharma side, life-sciences companies operate in a highly regulated environment. Clinical evidence, Computer System Validation, data integrity and complete documentation demand enormous resources — while market pressure, inspection intensity and time-to-market increase simultaneously. Software as a Medical Device (SaMD) and AI introductions add further complexity.

Our Approach

We support MDR-compliant product development as well as GxP qualification and validation projects to GAMP 5 — from building quality management systems to ISO 13485 and validating ERP, LIMS and DMS systems to audit-ready data integrity. Our consultants bring hands-on regulatory and validation experience from both medtech and pharma — delivering pragmatic, audit-ready documentation that withstands authority and Notified Body audits.

Relevant Services

01 Quality & Compliance 02 Data & AI 03 Enterprise & IT Service Management 04 Portfolio & Projects

What's Moving the Life-Sciences Industry

Guidelines · EU Commission

MDCG Guidelines on MDR Implementation

2028

The EU Commission and the Medical Device Coordination Group (MDCG) continuously publish guidance documents on MDR implementation — the transition deadline for Class IIb products runs until 2028.

View guidelines →

Swissmedic — therapeutic products authority

Authority · Swissmedic

Swissmedic — Medical Devices & Medicines

Swissmedic is the authorisation and supervisory authority for therapeutic products in Switzerland — responsible for conformity assessment, GMP inspections, vigilance and market surveillance.

Visit Swissmedic →

Pharmaceutical laboratory with GxP equipment

Guidelines · EMA/ICH

ICH Guidelines for GxP-Compliant Development

The ICH Q10 guideline on pharmaceutical quality system implementation is the global gold standard — the foundation for every regulatorily sound CSV and validation project.

View ICH guidelines →