Quality systems - QMS
Eumed® supports companies and professionals in the creation, implementation and certification of Quality Management Systems (QMS), guiding them in the choice of certification bodies most suitable and in staff training for autonomous quality management.
ISO standards (ISO 9001, ISO 13485, ISO 27001) are international technical standards designed to ensure that products, services and processes comply with business objectives and regulatory requirements. To these rules is added the Medical Device Single Audit Program (MDSAP Certification), which allows manufacturers to meet regulatory requirements in multiple countries, with a single audit.
In a highly regulated industry like that of biomedical, obtaining certification represents a competitive advantage and, in many cases, an essential requirement to operate on the market. Find out how we can support you in this delicate journey.
ISO 13485
Unlike ISO 9001, ISO 13485 it is specifically designed for companies in the field of medical devices and meets stringent international regulatory requirements. The main objective of this standard is to ensure the safety and effectiveness of devices through rigorous and traceable design, manufacturing, distribution and service processes.
The latest version, UNI CEI EN ISO 13485:2021, introduced new provisions for supplier control, risk management and device traceability. Furthermore, with harmonization ai Regulations (EU) 2017/745 (MDR), 2017/746 (IVDR) this standard has become a fundamental reference for regulatory compliance in Europe and internationally.
Do you want to receive support in obtaining certification ISO 13485?
ISO 9001 quality systems
ISO 9001 is an international standard applicable to any organization that wants to adopt an effective quality management system oriented towards continuous improvement. It does not just certify compliance with regulatory requirements, but promotes a strategic approach to quality, through constant monitoring and controls to guarantee the satisfaction of customers, partners and stakeholders.
The most recent version, ISO 9001:2015 / Amd.1:2024, introduced a stronger focus on risk management and the optimization of business processes, including attention to climate change factors, making the system more flexible and adaptable to different business realities.
Do you want to receive support in obtaining certification ISO 9001?
ISO 27001
In the biomedical sector, secure data management is essential, especially when it comes to clinical information, connected devices or sensitive patient and healthcare worker data. ISO 27001 is the international standard for information security management systems (ISMS) and provides a framework to protect company data from unauthorized access, loss and cyber attacks.
EUMED helps healthcare and biomedical companies implement an Information Security Management System compliant with ISO 27001, reducing risks and ensuring the protection of critical information.
Do you want to receive support in obtaining certification ISO 27001?
MDSAP Certification
The Medical Device Single Audit Program (MDSAP Certification) allows medical device manufacturers to simultaneously meet the regulatory requirements of multiple countries with a single audit. Currently, MDSAP is recognized by the authorities of:
- United States (FDA)
- Canada (Health Canada)
- Brasile (ANVISA)
- Australia (TGA)
- Japan (MHLW/PMDA)
Getting certified MDSAP facilitates access to global markets and reduces duplication of audits by regulatory authorities. Eumed® supports companies in the certification process, providing assistance in preparing documentation, adapting processes and managing inspections.
Do you want to receive support in obtaining certification MDSAP?
The certification process
and plan the certification path.
which includes the quality manual, operational procedures and evidence of their implementation.
so that it can manage the system independently.
which will evaluate the conformity of the system with the requirements of the standard.
valid for three years and subject to periodic checks.
Eumed® accompanies your company on the path towards certification, helping you choose the most suitable management system to your needs, whether it is streamlined and flexible or more rigorous and structured.
Our experts will support you in the design and implementation of the system, in identifying the most suitable certifying body and in staff training for effective quality management.
Our auditing service
Auditing is a complex evaluation process that involves an in-depth and impartial analysis of the quality management system, which aims to continuously improve company management and its growth. The auditing activity very often requires specialized skills.
Our audit service allows companies to optimize their management systems and ensure regulatory compliance, improving efficiency and minimizing risks.
Eumed® thanks to a team of experts, it can offer its expertise and professionalism in:
- Internal auditory
- Second party audit
- MDSAP audit