Explore Our ISO Standards Consultation Services
Our ISO quality standards consultation service provides specialized guidance in the medicine field, covering basic ISO, pharmacy, and environmental standards to help your organization achieve compliance and improve efficiency.
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Expert ISO and Regulatory Consultation for Quality in Medical Devices Industry
Experienced consultant will guide you through the complexities of ISO standards and regulatory requirements in the field of medical devices, ensuring your products and organization meets regulatory, industry and market requirements.
ISO 13485 – Quality Management System in the Medical Device Industry
The ISO 13485 standard is the most internationally recognized standard for quality management systems in the medical device industry. This standard is also the basis for quality management systems that may be specified in the regulatory requirements of individual regions or countries (e.g. MDR (EU), IVDR (EU), 21 CFR 820 (USA), TG(MD)R (Australia), RDC for Medical Devices (Brazil), SOR/98-282 (Canada), MHLW MO169 (Japan)). If you hold one of the following roles in the medical device industry, ISO 13485 is right for you: - manufacturer of medical devices - authorised representative of the manufacturer of medical devices - importer of medical devices - distributor of medical devices - contractor of installation (installation) and servicing (serviceman) of medical devices - supplier of materials, components, sub-assemblies for medical devices (if requested by your customers – manufacturers of medical devices, installers, service technicians) - contract manufacturer or original equipment manufacturer (OEM) of medical devices
Learn moreCE mark – Conformity of Medical Devices for the Needs of the European Union Market
The CE mark indicates the medical device complies with the regulatory requirements applicable to the EU market, either Regulation (EU) 2017/745 for general and implantable medical devices, or Regulation (EU) 2017/746 for in-vitro diagnostic medical devices.
Learn moreMDSAP – Unified Medical Device Conformity Scheme to Access Five Geographic Markets – Australia, Brazil, Canada, Japan, United States of America
The MDSAP scheme (Medical Device Single Audit Program) is an agreement to carry out a unified assessment of compliance with the regulatory requirements of Australia, Brazil, Canada, Japan and the United States of America. Manufacturers who want to offer medical devices in the listed countries can approach a single audit carried out by designated auditing organizations, thereby avoiding assessments by the regulatory authorities of the individual countries included in the MDSAP scheme, as the regulatory authorities recognize the results of the audits carried out by auditing organizations.
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Expert ISO Consultation for General Quality Management
Experienced consultant will guide you through the ISO standard requirements in the field of general quality management, ensuring your products, services and organization achieve customer satisfaction.
ISO 9001 – General Quality Management System
The ISO 9001 standard is a general standard for quality management systems and is intended for: - companies, regardless of size and industry, that offer products or services on the market; in some industries, standards for quality management systems are used, which are adapted to the specifics of each industry, e.g. ISO 13485, ISO 15378 - public sector organizations that offer and provide public services
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Expert ISO Consultation for Quality in Pharmaceutical Packaging Industry
Experienced consultant will guide you through the ISO standard requirements in the field of quality management in pharmaceutical packaging industry, ensuring your products meet comprehensive customers’ requirements in pharma industry.
ISO 15378 – Quality Management System in Pharmaceutical Packaging Industry
The quality management system standard ISO 15378 is intended for the manufacturers of primary packaging for medicinal products.
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Expert ISO Consultation for General Environmental Management Systems
Experienced consultant will guide you through the ISO standard requirements in the field of environmental management, ensuring your products, services and organization meet.
Environmental Management System – ISO 14001
The ISO 14001 standard is internationally the most recognized standard for environmental management systems and is intended for organizations that have an impact on the environment through their activities and the products and services they produce and provide. By following the provisions of the standard, it helps you manage your organization to minimize environmental impacts and prevent pollution as much as possible.
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