Gloved hand with syringe

ISO 13485: My journey to certification – infrastructure

I work from home, where I have a comfortable office, small lab and well-equipped workshop

As far as the ISO 13485 standard is concerned, these rooms (two spare bedrooms and my garage) and the equipment, tools, machinery, IT systems and services I use in client projects are all part of the infrastructure used for product realisation, and I should therefore identify and maintain them.

Gloved hand with syringe

ISO 13485: My journey to certification – assessment visit

I’ve just had a first assessment visit by CQS (Certified Quality Systems), the certifying organisation I’m working with. That left me with a pretty positive feeling that I’ll be able to achieve certification within two months.

CQS’s Allan Baskerville is a big fan of using flowcharts. I also found that making them is very illustrative, as it forces you to think about the key activities and decision points in your processes. Allan’s most used phrase in our conversation was “is there appropriate evidence to support that …”. In a fair number of cases I could say “yes” to that.

Gloved hand with syringe

ISO 13485: My journey to certification – preparation

The first thing I needed to do was to define the scope of the certification. In my case “product realisation” includes design and development but excludes series manufacturing.

If I make prototypes or models they are not stand-alone products, but secondary to the engineering documentation I’m delivering. This means that those clauses in the standard dealing with production issues—and for medical devices there are quite a few—are not applicable.

Gloved hand with syringe

ISO 13485: My journey to certification – prologue

I like to think I deliver a quality service. My deliverables do the job, I have little overheads, and my clients are happy.

I never felt the need to get a quality certification and deal with the associated paperwork. But I’m now discussing another medical device development project from concept through to CE-marking and production, and my client is new to the medical device arena. They do not (yet) have their own medical device quality certification, so I see this as a good opportunity to pursue ISO 13485 certification of the Panchromos Quality Management System (QMS). To get external validation that Panchromos can compete with the big consultancies in this field.

EMC testing

Does my product need a CE-mark?

Probably. By applying the CE-mark to a product, the manufacturer or importer indicates that the product meets all applicable EU regulations—mainly on end-user health and safety, but also on energy and material efficiency.

Many categories of products require CE-marking before they can be placed on the market: These include medical devices, electrical and electronic equipment, machinery, toys, pressure equipment and many others. They specifically exclude food, pharmaceuticals and chemicals. The European Commission (EC) has published the “blue guide”, which offers excellent if very wordy guidance.

Bad Piggies

Start 2014 with some construction challenges…

From the makers of Angry Birds: bring out your inner mad inventor in the Bad Piggies game—it reminds me of the 90’s game TIM (The Incredible Machine).

Forget specs, create curves

I don’t like to design to a detailed specification. In many cases designing to specification leads to mediocre value.

In other words, specs leave money on the table. My problem with specifications is that they are usually expressed as an all-or-nothing value proposition: If the spec calls for a maximum weight of 150g, then a design that comes in at 151g fails and has no benefit, whereas a marginally lighter one at 149g passes with full benefit. I would argue that in most cases this is too much of a simplification. In reality there will be a smooth benefit curve between “too heavy” and “impossibly light” – sometimes steep and sometimes shallow.

Sniffer bees in “The Engineer”

“Trained sniffer bees are the key components of new technology that could stop terrorists in their tracks”

The Engineer of this week has devoted a two-page spread to the sniffer-bee project we’ve been working on with Inscentinel for some time. It’s a very interesting and unusual project to work on…

Selfoc Lens Arrays

Selfoc Lens Arrays

I first came across Selfoc Lens Arrays (SLAs) about 20 years ago.

At that time I was working as a product development engineer for the Dutch copier and printer manufacturer Océ, and involved in the design of a meter-wide LED print head. We used an SLA spanning the full width of the printhead to project an image of a strip of over 10,000 LEDs onto a photoconductor drum.

Inscentinel VASOR

Sniffer bees on page 3

A prototype explosives detector I designed and built for Inscentinel was featured in an article by Richard Savill on page 3 of the Daily Telegraph—the full text follows:

Bees, latest weapon in the war on terrorism

Honeybees trained to sniff out explosives could soon be used at airports in the fight against terrorism.

Researchers have trained bees to extend their proboscis when smelling a particular explosive and have also developed a “sniffer box” to indicate when the bees show signs of detecting explosives. A spokesman for Inscentinel, of Harpenden, Herts, said teams of sniffer bees could one day be part of the screening process at airports and other venues, including museums and major sporting events.