Confidence in quality and compliance
Meeting the requirements of ISO 13485 and the Medical Device Regulation (MDR) is only part of the challenge. Organisations must also demonstrate that their medical devices remain safe, effective and compliant throughout the entire product lifecycle.
Normec provides independent audits, quality assessments and post-market surveillance (PMS) services. Our specialists help you manage risks, continuously improve your quality systems and prepare for audits and regulatory inspections.
Independent audits in accordance with ISO 13485
Audits play a vital role in maintaining quality management systems and regulatory compliance. Normec supports organisations with independent audits and periodic assessments of processes and quality systems.
Our services include:
- Internal audits of quality management systems
- Baseline assessments of processes and compliance
- Periodic surveillance and follow-up audits
- Unannounced internal audits
- Support in preparing for external audits and regulatory inspections
- Assessment of processes against ISO 13485 and applicable regulatory requirements
Post-market surveillance for continuous product safety
Post-market surveillance (PMS) is essential for ensuring that medical devices remain safe and effective after they have been placed on the market.
Our support includes:
- Establishing continuous feedback and monitoring systems
- Risk assessments and product performance evaluations
- Analysis of complaints, trends and market data
- Support for MDR compliance and CE conformity
- Translating regulatory requirements into practical quality processes
- Support from experienced quality assurance teams
With our support, you can:
- Continuously monitor and improve product safety
- Strengthen compliance with ISO 13485 and MDR requirements
- Identify and manage risks at an early stage
- Be fully prepared for audits and regulatory inspections
- Drive continuous improvement across your quality processes
Future-ready medical devices
Normec combines specialist expertise with extensive experience in the medical device and life sciences sectors. Our independent approach and in-depth knowledge of ISO 13485, MDR and CE conformity help organisations strengthen quality, safety and regulatory compliance.
Together, we build safe, compliant and future-ready products and processes.
Would you like to know more about audits and post-market surveillance?
Frequently Asked Questions
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An internal audit evaluates whether processes and quality management systems comply with internal requirements, applicable regulations and recognised quality standards.
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Follow-up audits help organisations maintain compliance over time and demonstrate continuous improvement.
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Post-market surveillance is the ongoing process of monitoring medical devices after they have been placed on the market to ensure their continued safety and performance.
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PMS enables organisations to continuously monitor product safety, performance and regulatory compliance while identifying potential risks at an early stage.
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Key regulatory frameworks include ISO 13485, the Medical Device Regulation (MDR) and CE conformity requirements.
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Yes. We support organisations with unannounced internal audits and preparation for external regulatory inspections.
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We support organisations operating in the medical device, healthcare and life sciences sectors.