Quality Assurance & Regulatory Affairs Compliance​​
Compliance designed to support growth, not slow it down
​KAHLITY helps medical device and drug–device combination companies build robust, risk-based, and scalable Quality and Regulatory frameworks. Our approach reduces uncertainty, prevents late-stage remediation, and enables confident growth across products and markets. We integrate Quality and Regulatory considerations early and pragmatically, where they have the greatest impact on timelines, cost control, and long-term value.
How we work
ASSESS:
We clarify regulatory risk and readiness, Quality Management System (QMS) maturity, and business priorities, while identifying where compliance effort creates real value.
DESIGN:
We design Quality and Regulatory systems that are fit for purpose, risk-based, and aligned with your strategy.
CREATE:
We implement QMS processes, technical documentation, and regulatory pathways, working hands-on with your teams.
VALIDATE:
We prepare organisations for audits and inspections, ensuring compliance can be demonstrated clearly and confidently, even under pressure.
IMPLEMENT:
We sustain compliance as your organisation scales, evolves, or expands into new regulated markets.
What we support
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Quality Management System (QMS) design, implementation, and improvement
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Key QMS processes (CAPA, complaints, risk management, change control, supplier management, audits)
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Technical documentation and legacy remediation
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Regulatory strategy, product registration, and market expansion
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Audit and inspection readiness
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PRRC (Person Responsible for Regulatory Compliance) services and ongoing regulatory oversight
Who we support
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Start-ups and growth-stage companies building their Quality and Regulatory foundations
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Small and Medium-sized Enterprises (SMEs) seeking certification, remediation, or market expansion
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Large organisations managing complexity, global operations, or acquisitions
Why KAHLITY
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ISO 13485–certified entities in Switzerland and France
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Deep expertise in medical devices and drug–device combination products
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Pragmatic, business-aligned approach
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Proven ability to support growth without compromising compliance
Efficient. Agile. Flexible.
OUR NORMATIVE AND REGULATORY EXPERTISE
Medical device ​regulatory requirements
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EU-MDR, Medical Device Regulation (EU) 2017/745
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EU-IVDR, In-Vitro Diagnostics Regulation (EU) 2017/746
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MedDO, Medical Device Ordinance
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IvDO, In-vitro Diagnostics Ordinance
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21 CFR Part 820 Quality System Regulation
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21 CFR Part 4 Regulation of Combination Products
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Artificial Intelligence Act COM(2021) 206 final
Medical device normative requirements
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ISO 13485 Medical Devices
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MDSAP, Medical Device Single Audit Program
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ISO 14971 Application of risk management to medical devices
Management Systems
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ISO 9001 Quality Management
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ISO 15189 Medical Laboratories
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ISO 19011 Guidelines for auditing management systems
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ISO/IEC 42001 Information technology - Artificial intelligence - Management system
GxP
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GMP, Good Manufacturing Practice
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GLP, Good Laboratory Practice
Environmental normative requirements
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ISO 14001 Environmental management systems
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ISO 14021 Environmental labels and declarations
Sterilization normative requirements​
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ISO 11135 Ethylene Oxide Sterilization
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ISO 10993-7 EO residuals
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ISO 11137 Irradiation sterilization
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ISO 17665-1 Moist heat sterilization
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ISO 17664 Information to be provided by the manufacturer
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ISO 11737-1 Bioburden
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ISO 11737-2 Sterility