E-06-50b. Integra MicroFrance Le Pavillon St Aubin Le Monial. Page 1 sur 6
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1 Integra MicroFrance Le Pavillon St Aubin Le Monial Page 1 sur 6
2 WHO ARE WE? E-06-50b Integra is active in more than 50 countries Founded in 1989, Integra is one of the international leaders on the medical devices market. Headquartered in Plainsboro (United States of America / New Jersey), Integra is listed on the NASDAQ Stock Marked (IART) and achieved a 928.3M$ turnover in Integra now operates in more that 100 countries with its distribution network and has a taskforce of 3500 people all over the world. Integra develops, manufactures and distributes implants, instruments and medical devices for neurosurgery, spine surgery, extremity reconstruction, reconstructive plastic surgery and general surgery. Integra is dedicated to limiting uncertainty for surgeons, so that they can concentrate on providing the best patient care. Integra MicroFrance Integra MicroFrance designs, manufactures, controls, distributes and repairs active or non-active surgical instruments, including electrosurgical instruments, dedicated to general surgery or specialized surgeries such as Ear-Nose-Throat surgery, plastic surgery, laparoscopic surgery. Integra MicroFrance has a taskforce of more than 100 personnes in its manufacturing facility in Saint-Aubin le Monial (03160), in the middle of France. MicroFrance devices are distributed in 35 countries. History : 1970 Creation of the company Ets BOUTMY MICROFRANCE at Bourbon l Archambault (03160) 1992 Setting up of MICROFRANCE in a new building at Saint-Aubin-Le-Monial (03160) 1999 / 2000 Acquisition of MICROFRANCE by groupe XOMED Group / XOMED group is acquired by MEDTRONIC Group 2014 Acquisition of MICROFRANCE by Integra LifeSciences 2017 Inauguration of a 1000 square meters new building dedicated to machining Our products : ENT (Ear-Nose-Throat) Instruments: Laryngoscopes / Forceps / Microsurgery, etc. Laparoscopic Instruments : Electrosurgical forceps / Trocars, etc. Instruments for plastic surgery and general surgery : Osteotomes / Mallets / Dissection forceps / Scissors, etc. Page 2 sur 6
3 OUR QUALITY POLICY Page 3 sur 6
4 OUR ENVIRONMENTAL POLICY Page 4 sur 6
5 OUR QUALITY & ENVIRONMENTAL COMMITMENTS Our main certifications & appliable regulatory requirements Quality ISO Certification - Medical Devices Quality management systems -- Requirements for regulatory purposes French & European regulatory requirement EC Certificate / Approval of full Quality Assurance System ANNEX II excluding section 4 Directive 93/42/EEC concerning medical devices; French Code of public health American regulatory requirements (FDA) - Quality System Regulations (QSR) 21 CFR Part 820 Canadian regulatory requirements - Canadian Medical Device Regulation (CMDR) Other regulatory requirements depending on the final geographical destination for our products Environment ISO Certification Environmental Requirements with guidance for use European & French regulatory requirements (French Code of Environment), including regulation on «Installations Classées pour la Protection de l Environnement (ICPE) Our quality approach with our suppliers: Selection & follow-up according to the type & criticality of the products / services provided including : Self assessment concerning quality, environment & processes/technologies Agreements : quality agreement, framework agreement, distribution agreement, non disclosure agreement Audits at regular intervals Establishment of purchasing specifications: Instructions / Drawings / Specifications / Design brief etc. Documentary requirements for purchase order according to the type of product / service provided: Delivery note / Certificate of Conformity / Raw material Certificate, etc. Performance monitoring on the quality performance based on quantities delivered and/or the delivery performance Incoming inspection adapted to the performance of the supplier and/or the criticality of the product in order to determine the conformance of the products supplied with the purchasing specifications. Development of partnerships with our more competitive suppliers. Our environmental approach with our suppliers : Favor local suppliers/subcontractors in order to minimize the environmental impact of raw materials of our products. Purchase steel of European origin Purchase eco-friendly & sustainable supplies (Ecolabel /FSC / PEFC, etc.). Page 5 sur 6
6 Encourage an environmental approach among our suppliers with the promotion of ISO certification and / or the establishment of measures aiming to reduce the impact of the company and its activities on the environment. Identify ways to reduce/find alternatives to the packaging of purchased products, i.e. packaging reuse, packaging recycling. CONTACTS Purchasing Quality Environment Raw materials / Machined components / Service deliveries / Utilities Nathalie FRIAUD +(33) (0) nathalie.friaud@integralife.com Instruments Maeva DORIATH maeva.doriath@integralife.com +(33) (0) Thérèse SUN KRYS +(33) (0) therese.sunkrys@integralife.com Nathalie DATIN +(33) (0) nathalie.datin@integralife.com Page 6 sur 6
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