The ISO-13485 is an ISO standard, which describes the requirements for a Quality Management System for the design and manufacture of Medical Devices.

It is an extension of the ISO-9001. Whereas the ISO-9001 focuses on customer satisfaction and continuous improvement, the ISO-13485 focuses on product safety.

Compliance with ISO-13485 is often seen as the first step in achieving compliance with European Regulatory requirements. The conformity of Medical Devices and In-vitro Diagnostic Medical Device according to the different MDD’s must be assessed before sale is permitted. The preferred method to prove conformity is:
1. the certification of the Quality Management System according ISO-13485 and
2. a Technical Product  File review
by a Notified Body. The result of a positive assessment is the certificate of conformity, allowing the CE mark and the permission to sell the medical device in the European Union.

Due to a lot of scandals like e.g the French breast implants, the regulatory requirements are becoming more and more strictly. But also the high speed technology improvements ask for a clearer definition: e.g.
• Can standalone software be a Medical Device ?
• An App on your mobile phone, that can recognize a skin-tumor, is that a
  Medical Device ?

Argo Consultancy has a lot of experience on Quality Management Systems, on both sides of the QMS-table:
• Setting up Quality Management Systems according to the ISO-13485
• Auditing Quality Management Systems on its compliancy with the ISO-13485
It is evident that sitting on both sides of the table has a lot of advantages for both sides on the table.
(Of course auditing my own work is not allowed).

My expertise:
• Setting up compliant Quality Management Systems:
    • That gives enough details to be helpful in supporting the business
    • That is global enough to prevent from being bureaucratic and not being used
• Motivate people to define the QMS, to work with it and to improve it
• Having seen so many good examples to realize your wishes in a minimum of time
and it fits with my slogan:  

Argo Consultancy: Your Drive to Quality

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Written by Hans Jonker

Category: ISO

Last Updated: 22 May 2014

The goal of the NEN-platform is to actively exchange and discuss the developments, experiences and knowledge in the area of software and medical devices, where experiences and problems are taken into consideration.
The NEN-platform has not been embedded in the existing structure of the standard NEN committees, but takes a place between these NEN- committees.
The NEN-platform gives asked and unasked advice to the related NEN-committees in the medical care (303006) and medical electronic devices (301062), general medical appliances (301002) and/or policy committees in these areas, in a consulting role.

Target members for this NEN-platform are organizations, which are concerned or are otherwise involved at this subject, are invited to take part in the NEN-platform. The following parties are important stakeholders:

• Manufacturers
• Suppliers
• Medical Care providers
• Users
• Consultants
• Government

From the start of the NEN-platform, Argo Consultancy is member of this NEN-Platform: ‘Software and MDD’

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Written by Hans Jonker

Category: ISO

Last Updated: 22 May 2014

Argo Consultancy is certified to perform audits for the DEKRA. After an extended training period, with al lot of training courses, but also with a large series of guided trainings-audits and successfully finalized with an examination audit.
Being a subject specialist on my technical area (Active Devices), was a must for the DEKRA for having added value to her customers.

On a regular basis the DEKRA observes all their contractors during an audit to be sure that the audits are performed well, as they expected.

On a regular basis the RvA audits Notified Bodies (as the DEKRA) on being compliant with the auditing standards.
The RvA also observe audits performed by the DEKRA. I once have had the honor of being (successfully) witnessed by the RvA.

During the years I have followed a lot of trainings in the area of Vigilance, Risk Management, CE-marking, FDA-QSR, which are very helpful during the certification audits.

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Written by Hans Jonker

Category: ISO

Last Updated: 22 May 2014

It is very important to determine:
• if your product is a Medical Device
• if it is a MD or an In Vitro MD,
• which class it is
because it determines what you have to do before you may sell the product (CE-Routes) on the Community Market.

Medical Device
• Definition [MDD]:
‘medical device’ means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be
used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:
— diagnosis, prevention, monitoring, treatment or alleviation of disease,
— diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
— investigation, replacement or modification of the anatomy or of a physiological process,
— control of conception,
and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.

• Determine with help of MedDev 2.1/6 the first Flow, if your product is a MD or not.

In Vitro Medical Device
• Definition [IVDD]: 
‘in vitro diagnostic medical device’ means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, or system, whether used
alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally
for the purpose of providing information:
— concerning a physiological or pathological state, or
— concerning a congenital abnormality, or
— to determine the safety and compatibility with potential recipients, or
— to monitor therapeutic measures.

Specimen receptacles are considered to be in vitro diagnostic medical devices. ‘Specimen receptacles’ are those devices, whether vacuum-type or not, specifically intended by their manufacturers for the primary containment and preservation of specimens derived from the human body for the purpose of in vitro diagnostic examination.

Products for general laboratory use are not in vitro diagnostic medical devices unless such products, in view of their characteristics, are specifically intended by their manufacturer to be used for
in vitro diagnostic examination;

• Determine with help of MedDev 2.1/6 the second Flow, if your product is a MD or IVD.

Determine the Class
• For MD use: MedDev 2.4/1

• Class I, Is, Im  : medical devices with a low risk 
                        (special sub-class for Sterile and with Measurement function)
• Class IIa, IIb    : medical devices with a medium risk
• Class III          : medical devices with a high risk

• For IVD use: IVDD Annex II

• Being on List A or B        : IVD medical devices with a high risk
• Not being on List A or B  : medical devices with a low risk
                                       (special sub-class for Self-test) 

Details

Written by Hans Jonker

Category: ISO

Last Updated: 22 May 2014