ISO 13485 in software development

When it comes to implementation of a new product connected with medical sector in EU, the first thing that has to be considered is ISO 13485 certificate. It was published for the first time in the 1996 and it represents requirements and quality standards for each  medical device approaching the market. The current version of the certificate is dated on 1st march 2016.

About ISO 13485

ISO 13485 is often comparable to ISO 9001. The main difference is that the latter is strictly connected with constant improvement analysis, whilst 13485 needs to be documented just as an efficient and safe at the release date. To implement ISO 134585 certificate, the entity needs to incorporate following standards:

  • Analysis in form of audit
  • Configurated schedule of implementation
  • Introducing system
  • Training course for workers and distributors
  • Training for internal ISO specialist
  • Proceeding of external audit
  • Preparations for certificate

To successfully receive the certificate, all factors mentioned above has to be contained.

Certification in software development

iso certification

Most of new medical devices are directly connected with IT sectors, especially software industry. Programming is inevitable for today’s technology, so it is include software technology at the very beginning of designing new endeavor.  It is worth considering contracting out the process of development of the new software structures to outside company. We asked Pro4People what are the most valuable pros of such solutions and here we present the shorten list of the ones we think are the most interesting from the entrepreneur point of view:

  • It helps saving both time and money – every software project is slightly different, but if you depute this task to the team of professionals with wide experience, they have got a head start from the very beginning. There is a high chance that they will also comply with such an obligation much faster – it saves you time and money you would have to put into training of interior specialist.


  • The quality of the development is absolutely uncompromised. The key is to compile a deliberate contract so that you can be calm everything will be done as planned. It is also possible to have an insight at any time of the realization to improve potential error and make the product even better than in basic assumptions.


  • Minimalizing risk of detrimental details that might be crucial for the final effects of the project. Team work is the key for a good market entry. Combining experience of independent software developer with unique vision brings the best results.

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Pro4People is a well-known IT company providing highest quality business solutions

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