Bioana Blog

Bioana Achieves ISO 13485 Certification: A Step Forward in Medical Device Excellence

At Bioana, we are thrilled to announce that we have achieved ISO 13485 certification, an international standard that confirms our commitment to quality and safety in the design, development, and manufacturing of medical devices.

Why choose a Development Partner that also offers Contract Manufacturing?

In the medical device industry, contract development and contract manufacturing has become a fundamental pillar for speed to market. By outsourcing with experienced partners, startups are able to mitigate risks, reduce costs and investment, and reduce lead times.

The Importance of Low-Volume Manufacturing in Medical Devices

Most medical device startup companies fail during one critical phase of the development process, the transition from prototype to market-ready product. Quite a challenge. But one that Bioana has helped its partners overcome in the past. 

Do you know the difference between verification and validation?

Verification and validation are necessary to comply with regulations and design a high-quality product that results in fewer mistakes, better repeatability, lower production costs, and faster time-to-market.

The Importance of a FDA 510(k)

All you need to know about a 510k. The more you know are the better the outcome.

Design Thinking in Medical Devices. What is ideation, prototyping and testing?

The design of a product or device, including those that are medical devices, must take into account the experience of users and patients, as well as usability. In today's market the focus should be on patients, so it’s necessary to improve their experience.

A new Vision, through the Bionic Lens

Do you really need to talk to 100 customers before building your idea?

Every idea needs to be tested, and talking to people seems at first the best choice. But, how many should I interview? Learn how to test your idea for successfully launching.

How to get to market fast? And successfully

Overcome challenges and take the right decisions at the right time with these 6 tips for successful and fast product development.

What is Technology Readiness Level? Why is it important?

Learn how the Technology Readiness Level can help you win investors and advance in the launch of your medical device.