QMS Consultancy : ISO 9001:2015 & ISO 13485:2016
Med devices Life sciences provide guidance for compliance on two major quality management standards. ISO 9001 : 2015 & ISO 13485:2016. While ISO 9001:2015 is a quality management system that provides general management systems to document, organize and define how a business will run its overall operations. It applies to all the organization, regardless of size or industry.
ISO 9001 helps organizations to ensure that high quality products and services is provided to their customers consistently re, which in turn brings, including satisfied of customers, as well as of management, and employees. Other benefits of ISO 9001 are:
- It organizes a QMS
- It creates satisfied customers, management, and employees
- It helps in continual improvements of the organization
ISO implementation changes the overall work culture of an organization. it also provides financial benefits, such as cost savings and profits. The organizations that are using ISO 9001 are encouraged to update themselves to ISO 9001:2015 as soon as possible. This is mandatory for not only organizations that are already certified to ISO 9001:2008, but also the organizations involved in QMS training or certifying others.
ISO 13485 states the international standard requirements for a QMS specifically aimed for medical devices. The basic requirements of ISO 9001 & ISO 13485 as ISO 13485 is based on the requirements of ISO 9001 so Just like other standards, ISO 13485 includes the entire ISO 9001 standard with additional requirements (for medical devices) included in blue italics text.
ISO 13485 is also required for regulatory purposes as well as non-statutory requirements for a quality management system that sets one the major distinction of ISO 13485 from its parent standard 9001.ISO 13485:2016 is the latest, and most current version of ISO 13485 series. This standard specifies requirements for a quality management system (QMS) centered around the medical device system, focusing on the needs of customers and applicable regulatory requirements.
ISO 13485 applies to all the suppliers and external parties that are involved in the different stages of medical device life cycle starting from from design and development to distribution and servicing, and this standard is developed to be used in organizations no matter what their role in the life-cycle.
CE mark is a kind of compliance mark for placing your product in EU market. It opens the doors for all the 28 major countries of EU for the device and also symbolizes the highest level of product quality. There are many steps involved in obtaining the CE mark. The first step is the defining the intended use of the device according to which is classification of the device is done as per the Annex IX of the medical device (MDD 93/42/EEC).The classification is often done based on the risk a medical device imposes. The lower risk device is class 1 and higher risk is class II and highest risk device is class III device.
If a product falls is Class I then the product can be self certified without the involvement of a notified body when as the class II and class III device require Notified body. for both self certification case and other certification a technical dossier is prepared for the product. This technical dossier contains all the information about the product from the raw material to test performed on the product , risk analysis , ESR, declaration of conformity, Manufacturing process description etc.
Once this file is approved by the NB then the onsite audit of the organization is done to ensure the things are actually at place as described in the technical dossier. The organization may or may not receive non conformity (NCs) during the audits. The major NC’s needs to be resolved within one month where as the minor can be resolved in 2-3 months. Once all NC’s are cleared the organization is finally issued the CE certification having a validity of 5 years subjected to surveillance every year.
While the process of CE is not very easy but the proper consultancy and guidance can help an organization to obtain CE smoothly. Med devices Life science Pvt. Ltd. provides consultancy for CE marking. We are in this field from the last 25 years and our organization is one stop solution for all the process & procedures related to the CE certification .We have our association with the Notified bodies in Europe and highly qualified approved auditor having the in depth knowledge of CE mark. Right from the product classification to preparation of technical dossier, conducting audit for compliance and providing the certificate we have gain our expertise in all the fields.
IEC 60601 pretesting
Electro medical device mainly consists of electro medical equipment and system. The equipment performs the functions or takes input for a function and the system display the output. The IEC 60601-1 addresses risks associated with electronic medical devices –this standard has become a de facto requirement for most companies manufacturing electro medical equipments. The standard does not cover the in vitro devices and medical gas pipelines. The objective of the standard is to measure the essential performance and safety of the devices
First and foremost whenever a device is received for testing purpose it is visually inspected. Visual inspection has many parameters. The visual inspection starts with checking the devices for general transport related damages, then the devices is checked for markings and other applicable sign and safety symbols..Every Device when tested for the general standards is then tested as the applicable particular 60601 standards for additional required.
This standard has many changes since its first edition was published and recently 4th edition of the IEC60601 standard is out which is , slated for adoption in 2018. The fourth edition emphasize on” design consideration” while manufacturing the next generation medical equipment.
EN 60601 standards cite three classifications for medical equipments namely: class CF, BF, and B based on safety & performance level as per EN60601-1-2 of medical device applied parts. Out of all three CF, or Cardiac Floating, is the most demanding performance level. Applied parts falling under this rating have direct connection with patient’s heat during the operation. Examples include ventricular assist device (VAD’s or dialysis machine).Applied parts which have long-term conductive contact with a patient comes under Type BF or Body Floating is less stringent than CF .Example of BF types includes incubators, patient heating and cooling equipment, ultrasound monitoring, cardiac monitoring, long term diagnostic equipment and blood pressure monitoring .
The least stringent safety requirement is for the type B, or Body, classification where the body parts are non- conductive and can be immediately taken off the patient body. Examples of B type includes, LED lighting, medical lasers, medical imaging, hospital beds and photo-therapy equipment. Another major difference between the 3 which can be notated is that type B is connected to earth ground where as both type BF & CF are not grounded that is why also they are known as floating.
Now testing as per IEC 60601 is mandatory for all electro-medical devices aimed for obtaining CE mark. While 60601 is not a single standard and it has a services of standards involved within specially aimed at different devices. It is mandatory to understand the requirements of your device as per IEC 60601. SO before going for the testing is is necessary to opt for a pretesting consultancy so that you can understand the in-depth the requirements needed for performing your product testing so that once the testing stats it does not get hold due to the requirement which needs to be fulfilled earlier. We have the technical experts who can pay visit to specially examine your product and pre-define the requirements and standards applicable on your product.
We also have a NABL accredited lab based at Mohali (Punjab) . We offer medical testing for compliance with this standard. We can also issue the CE mark after successful product testing against applicable standards. We can also provide test reports for your technical files for European and U.S. Food and Drug Administration (FDA) approval submissions