Quality management according to ISO 13485 - Excellence in medical technology
ISO 13485 is the international standard for quality management systems in medical technology and provides the basis for the safe and compliant design, manufacture and maintenance of medical devices.QMS for Clinical Trials – Regulatory Compliance and Highest Data Quality.
Our experts will guide you from initial analysis through to successful certification:
- Implement customised processes: Build a robust QMS that covers all ISO 13485 requirements.
- Risk Management and Process Control: Standardised procedures to minimise sources of error and increase product safety.
- Continuous improvement: Regular audits and optimisations to meet ever-changing regulatory requirements.
You can rely on our expertise to make your products safe, efficient and marketable on an international scale – with a QMS that meets the highest standards.
Quality management according to ISO 13485 - Excellence in medical technology
ISO 13485 is the international standard for quality management systems in medical technology and provides the basis for the safe and compliant design, manufacture and maintenance of medical devices.QMS for Clinical Trials – Regulatory Compliance and Highest Data Quality.
Our experts will guide you from initial analysis through to successful certification:
- Implement customised processes: Build a robust QMS that covers all ISO 13485 requirements.
- Risk Management and Process Control: Standardised procedures to minimise sources of error and increase product safety.
- Continuous improvement: Regular audits and optimisations to meet ever-changing regulatory requirements.
You can rely on our expertise to make your products safe, efficient and marketable on an international scale – with a QMS that meets the highest standards.
SOP development: structured processes and clear results
With customised Standard Operating Procedures (SOPs), you can increase efficiency, ensure regulatory compliance and create transparent processes – for greater consistency and sustainable success.
Standard Operating Procedures (SOPs) form the backbone of an effective quality management system. They provide clear and comprehensive definitions of how processes should run within your company, covering everything from routine work to complex procedures.
Our SOP development services include:
- Process documentation: Precise recording and documentation of your workflows.
- Regulatory compliance: Creating SOPs that fulfil all relevant legal and normative requirements.
- Increased efficiency: Standardised processes minimise sources of error and boost operational efficiency.
- Customisation: We offer tailor-made solutions that are precisely tailored to your company’s needs and structures.
- Continuous optimisation: Regular reviews and updates ensure that processes remain effective and up to date.
Rely on our expertise in SOP development to create a solid foundation for sustainable corporate success and the highest quality standards.
SOP development: structured processes and clear results
With customised Standard Operating Procedures (SOPs), you can increase efficiency, ensure regulatory compliance and create transparent processes – for greater consistency and sustainable success.
Standard Operating Procedures (SOPs) form the backbone of an effective quality management system. They provide clear and comprehensive definitions of how processes should run within your company, covering everything from routine work to complex procedures.
Our SOP development services include:
- Process documentation: Precise recording and documentation of your workflows.
- Regulatory compliance: Creating SOPs that fulfil all relevant legal and normative requirements.
- Increased efficiency: Standardised processes minimise sources of error and boost operational efficiency.
- Customisation: We offer tailor-made solutions that are precisely tailored to your company’s needs and structures.
- Continuous optimisation: Regular reviews and updates ensure that processes remain effective and up to date.
Rely on our expertise in SOP development to create a solid foundation for sustainable corporate success and the highest quality standards.
Internal audits: efficient quality assurance and sustainable process optimisation.
Internal audits are a key part of an effective quality management system. They provide an opportunity to regularly and systematically review existing processes, identify weaknesses, and implement targeted improvement measures.
Our internal audit services include:
- Systematic review: Structured audits to analyse and evaluate your internal processes and procedures.
- Compliance assurance: Ensuring compliance with internal guidelines and external legal and normative requirements.
- Data-based analysis: We create detailed audit reports that provide clear recommendations for action and opportunities for improvement.
- Continuous optimisation: Supporting the implementation of corrective and preventive measures to increase efficiency and quality sustainably.
Make your organisation transparent, secure and future-oriented by relying on our expertise in conducting internal audits, and lay the foundation for continuous success.
Internal audits: efficient quality assurance and sustainable process optimisation.
Internal audits are a key part of an effective quality management system. They provide an opportunity to regularly and systematically review existing processes, identify weaknesses, and implement targeted improvement measures.
Our internal audit services include:
- Systematic review: Structured audits to analyse and evaluate your internal processes and procedures.
- Compliance assurance: Ensuring compliance with internal guidelines and external legal and normative requirements.
- Data-based analysis: We create detailed audit reports that provide clear recommendations for action and opportunities for improvement.
- Continuous optimisation: Supporting the implementation of corrective and preventive measures to increase efficiency and quality sustainably.
Make your organisation transparent, secure and future-oriented by relying on our expertise in conducting internal audits, and lay the foundation for continuous success.
GAP analysis. The difference between actual and target.
A comprehensive GAP analysis enables you to accurately identify the differences between your current status and your targets, such as standards or regulatory requirements like the MDSAP. This systematic approach helps you to pinpoint weaknesses in your processes and systems, enabling you to define specific measures to address these issues.
Our services at a glance:
- As-is analysis: A detailed record of the current state of your processes, systems and structures.
- Target definition: A clear definition of objectives and requirements based on best practice and regulatory requirements.
- Gap identification: A systematic analysis of the discrepancy between the current status and the target status.
- Action planning: Developing concrete action strategies to close identified gaps.
- Implementation support: Support with implementing and continuously monitoring optimisation measures.
You can rely on our know-how in GAP analysis to keep your processes sustainable, reduce risks and keep your competitive edge over the long term.
GAP analysis. The difference between actual and target.
A comprehensive GAP analysis enables you to accurately identify the differences between your current status and your targets, such as standards or regulatory requirements like the MDSAP. This systematic approach helps you to pinpoint weaknesses in your processes and systems, enabling you to define specific measures to address these issues.
Our services at a glance:
- As-is analysis: A detailed record of the current state of your processes, systems and structures.
- Target definition: A clear definition of objectives and requirements based on best practice and regulatory requirements.
- Gap identification: A systematic analysis of the discrepancy between the current status and the target status.
- Action planning: Developing concrete action strategies to close identified gaps.
- Implementation support: Support with implementing and continuously monitoring optimisation measures.
You can rely on our know-how in GAP analysis to keep your processes sustainable, reduce risks and keep your competitive edge over the long term.
MDSAP: simplified audits and global acceptance.
The Medical Device Single Audit Programme (MDSAP) enables manufacturers of medical devices to have their quality management systems audited in a single, integrated process.
MDSAP reduces the administrative burden and facilitates access to international markets by assessing the regulatory requirements of several countries simultaneously.
Our experts will prepare your company for the MDSAP audit in the best possible way, providing support throughout the entire process, from internal analysis to implementation of the necessary measures.
By doing this, you will ensure compliance with legal requirements and lay the groundwork for continuous process optimisation and long-term market success.
MDSAP: simplified audits and global acceptance.
The Medical Device Single Audit Programme (MDSAP) enables manufacturers of medical devices to have their quality management systems audited in a single, integrated process.
MDSAP reduces the administrative burden and facilitates access to international markets by assessing the regulatory requirements of several countries simultaneously.
Our experts will prepare your company for the MDSAP audit in the best possible way, providing support throughout the entire process, from internal analysis to implementation of the necessary measures.
By doing this, you will ensure compliance with legal requirements and lay the groundwork for continuous process optimisation and long-term market success.