ISO 13485 Certification

Established by International Organization for Standardization (ISO), ISO 13485 is a global regulatory standard for companies that design and manufacture medical products, devices and software. 

Compliance with this standard is established from auditing and certification. ISO 13485 certification is required by the manufacturers to sell their medical products in the international market. Similar to ISO 13485, 21 CFR Part 820 compliance is required for medical products sold in US market.

LMG provides assistance in ISO 13485 implementation which consists of

·        Preparing Quality Manual Documentation

·        Preparing evidence records to establish the conformity of regulation.

·        Creating awareness about the ISO standards among team members.

·        Arranging Internal Auditing to check the QMS is effectively implemented             and maintained.

·        Arranging for Certification body audit.

·        Maintain ISO 13485 implementation thereafter.

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CE Marking (CE mark)

CE Marking, also known as CE mark is a legal requirement for some product groups to market it into the European Union (EU).  The CE mark (CE Logo) shows that the product is suitable for its intended purpose and also meets the EU safety regulations. 

CE Marking for the medical devices or equipment is the affirmation that the product meets all the EU directives that is applicable to medical devices. 

By affixing the CE mark on the product, the manufacturer is stating, at its responsibility and conformity with all the legal conditions to get CE marking which permits the free movement of the sale throughout European Economic Area. 

Medical Device Directive (MDD) gives the fundamental requirements that manufactures and importer must meet to get CE mark and legally sell their devices in the EU.  Since there are many products comes under MDD, the particular requirements depends on the classification and intended use of the device.

In most of the cases, EU Notified Body is needed to assess the compliance with the directives before affixing the CE mark on the device.

MDD categorize medical devices into three types. 

Class I, Class I (S), Class I (M), Class II a Class II b and Class III.    Usually, the classification depends on the intended use of the device.

All Class I (S), Class I (M), Class II a Class II b and Class III devices requires Notified Body approval whereas Class I device doesn't need one.

Liberty Management Group Ltd. provide assistance in getting CE Mark of Medical Device

Our services includes

·        Medical Device classification according to MDD

·        Directives Identification and Regulations for the device

·        Implementation of ISO 13485

·        Technical file preparation.

·        Notified Body Identification

·        Assist in Notified Body audit

·        Preparation of Declaration of  Conformity

·        EC / EU Representative.

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