Safety and quality are non-negotiable when it comes to medical devices, making the medical device industry one of the most heavily regulated industries around. To ensure medical devices are fit for their intended purpose, manufacturers must meet strict quality control and product requirements. This in turn means adhering to ISO regulations, a set of processes designed to establish and maintain consistent levels of quality across the board.
What is the ISO 13485:2016 Certification?
The ISO 9001 is the international gold standard for quality management systems (QMS), enabling businesses to improve safety while reducing costs and legal risks. The ISO 13485:2016 builds on this further, helping to improve quality and safety standards specifically within the medical device industry. It does this by laying out the requirements for a QMS that helps organisations demonstrate their ability to consistently meet consumer and regulatory requirements.
Any processes an organisation needs to achieve ISO 13485:2016, but which are performed by a separate organisation, are still their responsibility. These are to be accounted for in their QMS by monitoring, maintaining, and controlling the processes.
This international standard responds to the most current QMS practices, including changes in technology, regulatory requirements and expectations. It places greater emphasis on risk management and risk-based decision making, while also responding to increased regulatory requirements for supply chain organisations.
Who is ISO 13485:2016 for?
From design, development and production to storage, installation and distribution, ISO 13485:2016 applies to companies handling any part of a medical device’s life cycle. This also includes related services, such as servicing and technical support, as well as suppliers or external parties providing parts and products to these organisations. It even applies to those providing services related to their QMS.
Medical devices range from bandages, in vitro diagnostic reagents and tongue depressors to the most advanced radiotherapy equipment, implants and disease screening software. These medical devices play an important role in the public’s welfare and are used for the following specific medical purposes:
- Diagnosis, prevention, monitoring, treatment or alleviation of disease;
- Diagnosis, monitoring, treatment, alleviation of or compensation for an injury;
- Investigation, replacement, modification or support of the anatomy, or of a physiological process;
- Supporting or sustaining life;
- Control or support of conception;
- Disinfection of medical devices;
- Providing information by means of in vitro examination of specimens derived from the human body.
Medical devices are designed to be used for one or more of the above medical purposes, on human beings, either alone or in combination.
The importance of ISO 13485:2016 for the medical devices sector
When it comes to medical device manufacturing, patient safety greatly depends on the quality and consistency of medical products. Ensuring the effectiveness, control and maintenance of your QMS is critical to customers, stakeholders, patients, users and regulatory agencies. As such, there is a growing expectation for international medical organisations to demonstrate their quality management processes and ensure best practices across all their operations.
ISO 13485:2016 can help put an effective QMS in place that keeps processes running efficiently and meets applicable regulatory requirements. It also makes a great auditing tool to test the effectiveness of your QMS. This gives manufacturers more confidence in their ability to achieve and maintain regulatory compliance on a consistent basis. As a result, it also helps them avoid unwanted surprises and failures that could compromise patient safety and harm their reputation.
Since more manufacturers require certification to do business with vendors, suppliers and service providers, this international standard also helps to improve an organisation’s marketability. It demonstrates their dedication to meeting strict regulatory requirements, gaining customer trust and helping to bring safe and effective medical devices to market quickly.
All of this means that being ISO certified is critical for anyone handling medical devices including designers, manufacturers, and distributors. Companies that achieve this international standard have the most effective QMS in place and are recognised as reputable and trustworthy.
Marketing medical devices outside the country where they were produced requires meticulous translation of all instructions and specifications. Here at Intertranslations, we have been helping major medical device companies meet regulatory and export requirements since 1996. As a global medical translation agency, we have built up an experienced team of professional medical translators and editors. Each member has been vetted, choosing only those with exceptional linguistic skills, technical writing expertise and expert knowledge in life sciences, biomedical engineering and medicine.
With over 25 years of experience, we deliver translations that meet all of your needs. Our high-quality language services comply fully with Regulation (EU) 2017/745 for medical devices and international standards, having recently acquired ISO 13485:2016 certification. We follow all the best practices for medical device translation and localisation at every stage, ensuring consistently high-quality translations of your medical device documents.
Translating your medical device documents
Whatever your project requires, we have the solution. We can provide you with quality translations in a timely manner thanks to the expertise of our linguists combined with cutting-edge translation technology. Using advanced translation memories, we can identify repeated segments which unlocks multiple benefits in terms of quality, speed and cost.
For each medical device translation project, we update a database of previously translated medical terminology, sentences, paragraphs and text segments. The translation memories then suggest identical or similar texts which have been previously translated. This is ideal for larger projects with tight deadlines, helping to speed up the translation of new content while ensuring consistency throughout for greater quality.
At Intertranslations, we create custom translation memories for each of our clients. This ensures that you receive timely delivery and consistency across all your medical device documents. Since you only pay for new and unique content, this also gives you the best possible price for your translation.
Certified translations for all your needs
When dealing with highly regulated industries within the government, medical, or financial sectors, it is also likely that you will need a certified translation. We can certify all your translated documents by issuing and signing a certificate of authenticity. This certifies that the original document – or an official copy – was translated by a professional translator and that the translated text is correct and complete. If you would like to learn more about our ISO certifications, translation technology or certified translation process, then feel free to get in touch with our team. We will help you find the right solution for your project, so you can meet regulatory requirements and ensure safe use of your medical devices.