Explore Our ISO Standards and Industry Regulations Consultation Services
Our ISO management systems standards and industry regulations consultation services provide specialized guidance in the industry of medical devices, pharmaceutical packaging industry and general industries, covering ISO and regulatory requirements, good manufacturing practice (GMP) for pharmaceutical packaging, and environmental requirements to help your organization achieve safe and conforming medical devices, ensure continuous improvement and maintain efficiency.
-
Expert ISO and Regulatory Consultation for Quality in Medical Devices Industry
Izkušeni svetovalec vas bo vodil skozi kompleksnost ISO standardov in regulativnih zahtev na področju medicinskih pripomočkov ter pomagal zagotoviti, da vaši izdelki in organizacija izpolnjujejo regulativne, industrijske in tržne zahteve.
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 Assessment 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. We are here to help you get prepared for such assessments.
Learn more -
Strokovno svetovanje ISO za splošno vodenje kakovosti en
Izkušeni svetovalec vas bo vodil skozi zahteve standarda ISO na področju splošnega vodenja kakovosti in pomagal zagotoviti zadovoljstvo strank z vašimi izdelki, storitvami in organizacijo.
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
Learn more -
Strokovno svetovanje ISO za vodenje umetne inteligence
Izkušen svetovalec vas bo vodil skozi zahteve standarda ISO na področju vodenja umetne inteligence in zagotovil, da bo vaša organizacija obravnavala tveganja, povezana z etiko, preglednostjo, varnostjo, zaščito in skladnostjo s predpisi skozi celoten življenjski cikel umetne inteligence.
ISO/IEC 42001 – Artificial Intelligence Management System
The ISO/IEC 42001 standard is a standard for artificial intelligence management systems and is intended for organizations that develop, deploy, use, or manage artificial intelligence systems, regardless of size or sector, e.g.: - organizations designing or developing AI systems - organizations using AI in products, services, or internal operations - organizations procuring or integrating third-party AI solutions - organizations needing to manage AI-related risks, ethics, and compliance - organizations seeking regulatory readiness and stakeholder trust
Learn more -
Strokovno svetovanje za ISO standarde za kakovost v industriji farmacevtske embalaže
Izkušeni svetovalec vas bo vodil skozi zahteve standardov ISO na področju vodenja kakovosti v industriji farmacevtske embalaže in pomagal zagotoviti, da vaši izdelki izpolnjujejo celovite zahteve kupcev v farmacevtski industriji.
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.
Learn more -
Strokovno svetovanje ISO za splošne sisteme ravnanja z okoljem
Izkušeni svetovalec vas bo vodil skozi zahteve standarda ISO na področju ravnanja z okoljem in vam pomagal zagotoviti, da vaši izdelki, storitve in organizacija izpolnjujejo te zahteve.
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.
Learn more -
Strokovno svetovanje o sistemih vodenja varnosti in zdravja pri delu po standardu ISO
Izkušen svetovalec vas bo vodil skozi zahteve standarda ISO na področju vodenja varnosti in zdravja pri delu ter zagotovil, da vaša organizacija zagotavlja varno in zdravo delovno okolje.
Occupational Health and Safety Management System – ISO 45001
The ISO 45001 standard is internationally the most recognized standard for occupational health and safety management systems and is intended for any organization, regardless of size, type, or industry, that wants to improve occupational health and safety performance. By following the provisions of the standard, it helps you manage your organization to prevent work-related injury and ill health, provide safe and healthy workplaces, fulfill legal and other requirements, improve OH&S performance, strengthen leadership and worker participation and reduce incidents, downtime, and costs.
Learn more