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For Medical Device Manufacturers: 4 Things Your Software Engineering Partner Must Have

4 Things Your Software Engineering Partner Must Have!

A guide for medical device and software manufacturers looking for a medical software engineering partner

Just as IT outsourcing by global business is predicted to grow for the foreseeable future, so too is software engineering outsourcing by the healthcare industry. Driven by the need to deliver innovative healthcare solutions in a competitive business environment, manufacturers are increasingly turning to outsourcing to fulfill their business objectives.

From experience, we know that manufacturers are reluctant to outsource medical software engineering — there is a genuine risk involved if you hire the wrong company. To mitigate those risks, I’ve compiled four basic requirements you should look for when partnering with a software engineering firm.

Here are the four requirements:

ISO 13485 CertificationISO Certification:
Make sure your partner has committed to quality. You should be looking for a partner that has invested in the systems that assure a competent QMS (quality management system) is in place. At the minimum, your IT partner should have ISO 13485 certification. Other certifications can be helpful, especially for the medical industry. You can review those here.

Your software engineering partner should be healthcare focusedHealthcare-Focused:
Ideally, your software engineering partner should be 100% focused on healthcare. You don’t want to bid your work to an overseas firm that builds apps, websites, or whatever comes along. Healthcare is unique in its complexity and security needs. Find a software engineering firm that has demonstrated experience in multiple health domains and a has a proven track record of healthcare software success.

Your software engineering partner should have FDA experienceFDA-Experienced:
This goes hand-in-hand with our previous requirement — your partner needs to have experience with FDA
regulations.Your software engineering firm should absolutely have a working familiarity with FDA 21 CFR Part 820 (quality system regulation) and FDA 45 CFR parts 160, 164 (HIPAA). They need to understand the process of assembling paperwork for a 510(k) premarket submission.

Your software engineering partner should have a flexible approach to quality systemsFlexible Quality System:
Outsource to a company that is willing to work within your quality system or can provide a system that is compatible with yours. Often, you will use a combination of the two, as long as you can align the systems. For instance, it can be desirable to have your partner perform software verification within their quality system, while you perform validation in your system.

The simple fact is that global IT outsourcing is on the rise, and for good reasons. Companies can benefit greatly by outsourcing many of their non-core engineering functions to specialized partners. However, it’s important to select your partner carefully — look for a qualified firm that can bring quality, expertise, and technological innovation to the table. And make sure they have the four criteria mentioned above!

(We recently put together a helpful infographic that helps you understand how to use outsourcing to make your health IT projects soar. Download it free here!)

Some additional helpful resources:

A review of ISO and IEC Standards for Medical Device Companies

5 Practical Tips to Apply Agile Methodology to Healthcare Software Engineering

Infographic: Learn to How to use Outsourcing to Make Your Health IT Project Soar

Learn How to Use Outsourcing to Make Your Health IT Projects Soar!

If you are looking to outsource software development, engineering, or prototyping, you need to download the new infographic put together by the team at True Process. This downloadable resource covers the why, the who, and the how of IT outsourcing for the healthcare industry.
Download the Outsourcing Infographic