As a manufacturer of medical device and products for use in healthcare, Merivaara pays the greatest attention to the quality of its products and operations.
Certified by Det Norske Veritas (DNV), Merivaara’s operations from R&D and production to marketing, sales and after-sales service comply with ISO 9001 and ISO 13485 (medical device) standards, and also with ISO 14001 environmental standards.
Products are thoroughly tested to comply with international and national standards and regulations. We also use environmentally friendly manufacturing processes and choose recyclable materials whenever possible.
To ensure that Merivaara Quality is applied in the whole product lifecycle, quality assurance plays a significant role already in the R&D process and product risk assessment.
Det Norske Veritas – a multinational company focusing on risk identification and management. One of the world's best-known notified bodies. Merivaara’s quality and environmental management system has been audited and certified by DNV.
EU Declaration of Conformity
In order to affix the CE marking the manufacturer or his authorised representative must follow the EC declaration of conformity procedure referred to in Annex IV of the Regulation (EU) 2017/745. This procedure must be completed prior to placing the device on the market.
The “EC declaration of conformity” is the procedure whereby the manufacturer or his authorised representative prepares the required technical documentation, puts into place corrective action and vigilance procedures and declares that the products meet the essential requirements set out in Annex I of the Regulation (EU) 2017/745.
A general international quality management standard that forms part of a company's quality assurance. It comprises all functions from product development to manufacturing and dispatch.
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 requirements and regulatory requirements applicable to medical devices and related services. The standard has been set for planning, development, manufacturing and installation, as well as maintenance and repair of equipment classed as medical device.
The standard includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. Because of these exclusions, organizations whose quality management systems conform to this International Standard cannot claim conformity to ISO 9001 unless their quality management systems conform to all the requirements of ISO 9001.
ISO 14001:2015 specifies requirements for an environmental management system to enable an organization to develop and implement a policy and objectives which take into account legal requirements and other requirements to which the organization subscribes, and information about significant environmental aspects. It applies to those environmental aspects that the organization identifies as those which it can control and those which it can influence. It does not itself state specific environmental performance criteria.
Finnish Packaging Recycling RINKI
Merivaara has been member of Finnish Packaging Recycling RINKI Ltd since 2006.
Finnish Packaging Recycling RINKI Ltd (formerly called The Environmental Register of Packaging PYR Ltd) is a non-profit firm, operating in conjunction with producer organisations in the packaging sector. It helps firms registered with Finnish Packaging Recycling RINKI Ltd and the authorities to fulfil packaging recovery obligations economically and easily.
Firms with a turnover of EUR 1 million or more that place packed products on the market in Finland hold a packaging recovery obligation/producer responsibility. By making a contract with Finnish Packaging Recycling RINKI Ltd a firm transfers the abovementioned obligation to the producer organisations.
Waste Electrical and Electronic Equipment Directive – an EU Directive that seeks to reduce the generation of electric and electrical waste and to promote its reuse and recycling. The producer is responsible for the recycling and waste management of electrical equipment.
Merivaara has been member of SELT since 2005.
SELT Association manages recycling, dissemination of information, registration, and other statutory obligations on behalf of its members. With other producer organisations SELT Association has established Elker Ltd as a company providing centralised services to manage practical affairs. More than 650 producers of electrical equipment are already acting through SELT.