The current economy makes turning to China for goods worthwhile. Even with manufacturing and custom parts, China organisations are more than willing to accept low MOQ’s to increase trade. All these things make it appealing for smaller businesses (and large…

ISO 9001 may be a business standard that's employed by over 1,000,000 organizations worldwide. It helps businesses achieve optimum operational efficiency by handling the basics of quality management systems. The requirements for ISO 9001 certification is…

Guide to getting certified to ISO 9001

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It's become the beer "ring pull" of the new millennia, we see, as you all probably do, discarded facemasks all over the place.

The EPA has recently released...

Safety in quality is very important in the medical devices space. Regulatory requirements are becoming increasingly stringent throughout the product lifecycle, with a focus being placed on competence, requirements, and design validation activities. In addition…

New edition of ISO 14971:2019. Medical device risk management – technical report and provisions of the standard. Change in the interpretation of risk management of medical devices. Changes to the standard from previous editions. New edition of ISO 14971:2019.…

Environmental Management System standard provides not only the environmental result, but also the result of financial benefits for the organization, whose activities are built on the principles of ISO 14001. ISO 14001 ISO 14001 (Environmental Management System…

Therapeutic commodities are health-related items. Medical implants may be utilized to treat or prevent disease, change the body’s fluid balance, avoid or detect pregnancies, and replace or remodel parts and structures of the body. Healthcare equipment like…

Adopting a management system is of utmost importance for every business to acquire a leading position in the marketplace. Having no standard certification means you are doing business without defining your goals and objectives. Hence, having no direction…

Safety requirements for medical devices have been shaped throughout the history of medical devices, gradually becoming more complex and complemented by new items. Medical device manufacturing is a fast-growing industry that offers increasingly sophisticated…

Safety requirements for medical devices

World Day for Safety and Health at Work (April 28) World history has a huge number of all sorts of events that have occurred throughout the existence of mankind. Holidays are divided into historical, state days, protection and support, as well as many others.…

World Day for Safety and Health at Work

Today the concept of “internal audit” is widespread in business. Many large enterprises and companies prefer to create their own internal audit services and departments, training their employees. Besides, there is a constantly growing demand on the labor…

Approaches to the organization of the internal audit function in a medical organization can be classical, focused on the International Framework for the Professional Practice of Internal Auditing, developed by the Institute of Internal Auditors. This organization…

How often have you come across people who themselves feel that their customers are not satisfied with the products or services they receive from their company? All of us are absolutely convinced of the high quality and competitiveness of our products or our…

AAMI Issues 60601 Based Amendments

ISO 27001 is the accepted method of confirming the quality of information security management system - Distinct Compliance Engineering

In every company, no matter how fine-tuned the elements of information security management are, there are threats, vulnerabilities and potential risks, so to be competitive and achieve business objectives, organizations must do everything possible to identify…