Frontier Therapeutics operates a quality management system which complies with the requirements of BS EN ISO 9001:2015 and all Repose products are manufactured to this standard.

Repose conforms to MDD 93/42/EEC and MDR 2017/745 and the following standards: BS EN ISO 9001:2015 Quality Management Systems. BS EN 13485:2016 Medical Devices- Quality Management Systems – Requirements for Regulatory Purposes. BS EN 14971:2019 Medical Devices – Application of Risk Management to Medical Devices. BS EN ISO 15223-1:2021 Medical Devices – Symbols to be Used with Medical Device Labels, Labelling and Information to be Supplied – General Requirements. BS EN ISO 10993-5:2009 Biological Evaluation of Medical Devices -Tests for In Vitro Cytotoxicity. BS EN 10993-10:2013 Biological Evaluation of Medical Devices – Tests for Irritation and Skin Sensitisation.

Fire Safety Regulations; BS7175:1989 – The Ignitability of Bedcovers and Pillows by Smouldering and Flaming Ignition Sources. BS EN 597 2015 parts 1&2 – Furniture – Assessment of the Ignitability of Mattresses and Upholstered Bed Bases. 16 CFR part 1632 – Standards for the Flammability of Mattresses and Mattress Pads. California TB117-2013 – Requirements, Test Procedure and Apparatus for testing the Smolder Resistance of Materials Used in Upholstered Furniture. California TB133-1991 – Flammability Test Procedure for Seating Furniture for Use in Public Occupancies.

Repose DOES NOT incorporate a substance as an integral part, which used separately may be considered a medicinal product as defined by European Communities Medicinal Products Directive (Directive 2001/83/EC, as amended) and Human Medicines Regulation 2012 (SI 2012/1916)’. Repose DOES NOT incorporate as an integral part any substance or human blood derivative as defined in point 10 of article 1 European Communities Medicinal Products Directive (Directive 2001/83/EC, as amended), nor is it manufactured utilising tissues of animal origin as defined by the same directive.

The Repose range does not contain any substances over 0.1% by weight described on the Candidate List of Substances of Very High Concern for Authorisation – EC Regulation 1907/2006 – REACH.

SUSTAINABILITY

Frontier recognises that sustainability is core to good business practice and believes that our business performance will improve in line with our enhanced focus on sustainability.

Frontier is accredited to ISO9001 and ISO14001, reflecting the excellence of the product design and manufacturing systems whilst continually assessing and actively working to minimise waste throughout the life-cycle of the product.

The management and all who work within Frontier are committed to the care of the environment and the prevention of pollution. The company ensures that all its activities are carried out in conformance with the relevant environmental legislation.