Bespoke Plastic Enclosure, Cover, Sloped Enclosure or Part: How to be compliant with ISO 13485?

Since 1985 we have been designing and manufacturing bespoke plastic enclosures, mainly for 3 business sectors

Health & beauty
Industry
Service & IoT
Construction

Our teams have a great deal of experience in supporting our clients and know the constraints of the application market.

The ISO 13485 standard is comparable to the ISO 9001 standard. It is a management system, more precisely a quality management system (QMS).

The exact title of the standard:
Medical devices — Quality management systems — Requirements for regulatory purposes.

What does this mean ?

ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.

Source : https://www.iso.org/

An ISO 13485 certified company must meet the following requirements:

compliance with regulatory requirements ;
control of special processes;
risk analysis throughout product development;
clinical trials and the long-term follow-up of these trials;
the organisation of material vigilance;
control of the traceability of the configuration of each medical device delivered.

When developing a bespoke plastic enclosure, our teams have the experience to address the 3 main aspects regarding medical device requirements.

Proper material classified by 13485

Devices designed and manufactured for the HEALTH & BEAUTY sector must be made of self-extinguishing material. Today, the American organisation Unterwriter Laboratories (UL) has established itself as the reference laboratory and leader in this field. When we talk about a self-extinguishing material, we are talking about a UL material. However, this is not explicit. UL is therefore only the name of the laboratory. The test method for determining the flammability level of a material is 94. The result and thus the flammability level is defined by a value between HB, V-0 and V-5.

To meet the requirements of a medical device and therefore the requirements of a company certified under Standard 13485, a material must be classified by Unterwriter Laboratories to UL94 V-0.

Manufacturing process control: ISO 9001 Certification

As an ISO 9001 certified company, LTP has full control over the manufacturing process. We are able to offer you a technical design adapted to your device and its application market and to ensure reliable quality throughout the life of your product.

Documentation

Documentation is an unavoidable need for you, an ISO13485 certified company. When auditing or certifying your equipment in the laboratory, we need to prepare documentation around your equipment in detail. LTP is at your side to provide Technical Data Sheets (TDS), drawings with all the technical specifications, the name of the raw materials used, a material traceability document with your order reference, the technical reference, the materials used per Technical File (DT).

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