Providers & Products

We have manufacturers, suppliers and service providers from the area Auditing of medical technology companies

no results

Ihre Produkte genau hier!

Ihre Suche lieferte keine Ergebnisse, aber Sie können sich mit Ihren Produkten und Leistungen auf dieser Seite präsentieren

Mit einem Eintrag auf Weltzentrum der Medizintechnik platzieren Sie Ihre Produkte und Dienstleistungen bei Google & Co. ganz weit oben und erreichen so jeden Tag mehrere Tausend potentielle Kunden aus der Medizintechnikbranche. Mehr Informationen gibt es auf der Firma eintragen - Seite.

1 - 6 by 6 results

Auditing of medical technology companies

Auditing of medical technology companies

A medical technology company must follow stringent guidelines for quality and safety in order to meet international, national, and regional regulatory requirements. In addition to the ISO 13485:2016 standard, the EU's Medical Device Regulation requires companies to be audited regularly to ensure that their processes and products are safe and effective. MDSAP is a relatively new program that was developed by the International Medicine Device Regulators Forum (IMDRF). It was created to avoid duplicating resources and prevent disruption to the manufacturing process of medical devices.

The most important requirement for medical technology companies is their quality management system. An ISO 13485 certification is the minimum standard required for legally marketing devices in the EU. After obtaining this certification, companies must undergo several surveillance audits, including an initial review and yearly surveillance audits. In addition to this initial inspection, companies must perform regular recertification audits to maintain their certification. The frequency and scope of the periodic assessments depend on the type and classification of the medical device.

Another requirement for ISO 13485 is the quality management system. Once an organization has this certification, it can apply for CE marking and legally market its products in the EU. The process starts with an initial audit, followed by periodic surveillance audits, which involve the examination of documentation and physical inspections of the manufacturing facility. In addition, the company must go through regular recertification audits, which are required to ensure compliance with the ISO 13485 standard. The scope of the audits depends on the type of device.

In addition to compliance audits, medical device companies must conduct quality management systems that ensure the safety of their products. The FDA mandates a specific set of quality control measures to make sure the products are safe. While it is the responsibility of each company to ensure product safety, it is also the responsibility of the FDA to monitor the performance of its subsidiaries. The agency's mission is to ensure that the products are safe and effective for patients.

Regulatory audits are conducted to ensure compliance with the requirements of medical device regulations. Depending on the type of device, the manufacturer may be interested in assessing the quality system of its suppliers. This is done to ensure that the products are safe and effective. The US FDA enforces good manufacturing practices and the Code of Federal Regulations. The Quality System Regulation describes the process that must be followed by all companies. The FDA carries out these audits and must abide by it.

As part of the responsibilities of manufacturers, MDSAP certification is a must-have in certain countries. In addition, MDSAP is equivalent to a CE certificate in the UK, so it is widely accepted in Brazil. MDSAP is a valid document in Japan, though it is not used for premarket approval applications. There are many advantages and disadvantages to MDSAP. As a result, MDSAP is an excellent option for all manufacturers.

Become a member of the “World Center for Medical Technology“

Become a digital exhibitor yourself in the online portal of the largest and best-known MedTech cluster region in Germany and inform the world of medical technology about your products and services as well as about news, events and career opportunities.

With an attractive online profile, we will help you to present yourself professionally on our portal as well as on Google and on social media.

Become a member
cd