Agile Methods

Medical Device Software … it can be done

 

 

If you are considering agile approaches, are transitioning to agile methods, or have already implemented some flavor of agile, we can help. 

FDA Compliance and EN 62304 Conformance

Risk-based, compliant, and lean

Tailored to your preferences

Mobile Medical Apps

Standalone Software and Medical Device Data Systems (MDDS)

Embedded systems

 

Click here to have one of our Agile Methods Compliance experts contact you

 

 

 

Why do you need to adapt agile processes?
Medical device software regulatory standard IEC62304 and associated FDA pre and post-market requirements can be a minefield even for experienced medical device developers and almost an impenetrable barrier to newcomers.  Agile approaches, while holding potential for great benefits, can exacerbate the problem and make matters worse, not better, unless some adaptations are made to meet regulatory requirements.

What to do? You do not need to abandon agile approaches; adapt by "hardening" your agile process – just enough to stay in line with agile tenets – through identifying and establishing Discipline Points.  Discipline Points are specifically designed and targeted modifications to help ensure your agile process complies with IEC62304, ISO14971, and related regulatory guidance.

Why we can help
SoftwareCPR® has extensive experience helping clients reduce the risk of potential disaster, ranging from money and time wasted to outright inability to get regulatory approvals, associated with medical device software.  We have used our special expertise in compliant medical device software practices to identify changes to agile approaches so you can get both agile’s promised benefits while meeting regulatory requirements.

 

 

 

How we can help
SoftwareCPR® can help at all three agile stages … when you are:

Š       Considering whether or not to go “agile,” by helping you understand regulatory considerations of using agile, if agile approaches make sense, and to design “regulatory friendly” adaptations up front.

Š       Transitioning to agile, by evaluating your chosen process and determining what, if any, changes need to be made, and then aiding the transition.

Š       Already have an agile process in place, by helping you best articulate and defend your approach – internally and externally – from a compliance perspective and cost effectively recovering any lost ground in meeting regulatory needs.

In all stages, we can help you with the complete process or work in conjunction with any internal or external agile experts you have already engaged.