Medcial Devices

 

 

Medical products 

The Medical sector is where I concentrate most of my work at the moment. The main difference from other sectors is the required documentation that development programmes of work have to produce to meet regulations. The main difference from other sectors is the required documentation that development programmes of work have to produce to meet regulations.

My experience is mainly on CE and FDA standards.  Each of them have similar requirements but with important difference that is best to know and understand before developing a product.

Within the medical sector, I specialize in drug delivery, and medical therapy, but have worked in diagnostics, surgical and other sectors. Nowadays, one of the key aspects of drug delivery is human factors engineering (or suability). In

Have experience developing medical devices, including drug delivery and diagnostics products. All design work is fully documented to create Technical Files that comply with CE and FDA regulations.

I am familiar with the most relevant ISO standards, such as:

-60601 (electrical safety)

-62304 (software)

-10993 (biocompatibility)

-14971 (risk management)

-62366 (usability)

 

 

 


 

Drug Delivery

 

 

 

Maximum attention to detail and understanding of complex regulatory regulations.

 

 

Diagnostics

 

 

 

Understanding of advanced technologies that require high tolerance processes.


 

 

Therapy devices

 

 

 

With patient outcome and experience as a priority to deliver the ideal treatment.

 

Surgical Devices

 

Precision, ergonomics and cost that improves complex procedures.

 

 

Intimate care

 

 

Understanding patient’s concerns and responding with appealing solutions

Wellness 

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 Finding the right balance between a consumer and medical product

 


Medical Development process

When developing medical products, it is critical to follow a rigid documentation process to deliver a thorough technical file or technical documentation in compliance with different regulatory requirements.

My approach is to follow a “V” model that aligns with ISO 13485 and with my stage gate process. This model sets out the documentation and quality requirements from early stages, including a detail look at risk management following 14971 processes and the required verification and validation stagey from the outset.    

 

 


 

Regulatory roadmap and strategy

A critical aspect of medical devices development is to have a clear understating of the regulatory process, documentation requirements and define a regulatory strategy.

The chart below describes how complex tis the regulatory documentation workflow and that having a good planning in this area will help delivering the required documentation at each stage.

To learn more about the regulatory strategy, look here

 

 

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