EC Certificate - Full Quality Assurance System

Transcription

1 No. CE In respect of: See certificate scope page. on the basis of our examination of the quality assurance system under the requirements of Council Directive 93/42/EEC, Annex II excluding section 4. The quality assurance system meets the requirements of the directive. For the placing on the market of class III products an Annex II section 4 certificate is required. For and on behalf of BSI, a Notified Body for the above Directive (Notified Body Number 0086): Frank Lee, EMEA Compliance & Risk Director First Issued: 30 June 2014 Expiry Date: 25 September 2016 Page 1 of 2 Validity of this certificate is conditional on the quality system being maintained to the requirements of the Directive as demonstrated through the required surveillance activities of the Notified Body. This approval excludes all products designed and/or manufactured by a third party on behalf of the company named on this certificate, unless specifically agreed with BSI. This certificate was issued electronically and is bound by the conditions of the contract.

2 Certificate Scope: Design, Development, and Manufacturing of Guidewires, Angiographic Catheters, Guide Catheters, Radio Frequency Ablation Catheters, Diagnostic Mapping, Pacing, and Recording Catheters, Mapping Systems, Electrosurgical Electrodes, and Generators, Recording and Amplifier Systems, Including Software, Percutaneous Catheters, Stents, Needles, Dilators, Accessories, Introducer Catheter, Drainage and Urological Catheters, Urological Irrigation, Biliary Devices, Biopsy Devices, Retrieval Devices, Nephrostomy Devices, Feeding Devices, Ligators, Polypectomy Devices, Hemostasis Devices, Sphinctertomes, Suturing Devices, Endoscopes, Atrial Appendage Closure Devices and Sterile Delivery Systems, and minimally invasive tissue and thrombus removal devices. Those aspects of Annex II related to securing and maintaining the sterility in the manufacture of the ACUITY LDS Accessories, Cannulas, Fluid Administration Devices, Exchange Devices, Umbilical Cables, Cables and Accessories. Those aspects of Annex II related to maintaining the metrology function of inflators and accessory devices. First Issued: 30 June 2014 Expiry Date: 25 September 2016 Page 2 of 2 Validity of this certificate is conditional on the quality system being maintained to the requirements of the Directive as demonstrated through the required surveillance activities of the Notified Body. This approval excludes all products designed and/or manufactured by a third party on behalf of the company named on this certificate, unless specifically agreed with BSI. This certificate was issued electronically and is bound by the conditions of the contract.

3 Availmed S.A de C.V. C. Industrial Lt. 001 Mz. 105 No Int. A Col. Cd. Industrial Tijuana, Baja California Mexico Availmed S.A. de C.V. Ave. Paseo Reforma No C.P La Mesa, Tijuana, Baja California Mexico Bard Electrophysiology A Division of C.R. Bard Inc. 55 Technology Drive Lowell MA Design Page 1 of 17

4 Bard Glens Falls Operation 289 Bay Road Queensbury New York Boston Scientific Way MA 150 Baytech Drive San Jose CA First Street Propark, El Coyol, Alajuela Costa Rica Design Labelling Packaging Page 2 of 17

5 302 Parkway Global Park Heredia Costa Rica 4100 Hamline Avenue North St. Paul MN Lakeview Boulevard Fremont California Design Design Page 3 of 17

6 5905 Nathan Lane Plymouth Minnesota Brookside Drive Spencer IN Evergreen Blvd. NW Minneapolis Minnesota Design Page 4 of 17

7 9055 Evergreen Blvd. NW Minneapolis Minnesota Two Scimed Place Maple Grove Minnesota Boston Scientific Limited Ballybrit Business Park Galway Ireland Boston Scientific Limited Ballybrit Business Park Galway Ireland Design EU Representative Page 5 of 17

8 Boston Scientific Limited Business and Technology Park Model Farm Road Cork Ireland Boston Scientific Limited Cashel Road Clonmel Co. Tipperary Ireland BSC Coventry 8 Industrial Drive Coventry Rhode Island Labelling ETO Sterilization Page 6 of 17

9 Creation Technologies LP 3939 North Fraser Way Burnaby British Columbia V5J 5J2 Canada Creation Technologies LP Fraserton Court Burnaby British Columbia V5J 5H8 Canada Dedicated Computing LLC N26 W23880 Commerce Circle Waukesha Wisconsin Crucial Supplier Page 7 of 17

10 FMD. Co., Ltd Shimo-obari-nakashima Komaki-shi Aichi Japan Lake Region Medical 340 Lake Hazeltine Drive Chaska Minnesota Merit Medical Systems, Inc. 65 Great Valley Parkway Malvern PA Design Control of Sterilization Page 8 of 17

11 Minnetronix, Inc Energy Park Drive St. Paul Minnesota Navilyst Medical, Inc. 10 Glens Falls Technical Park Glens Falls NY Nothern Digital, Inc. (NDI) 103 Randall Drive Waterloo Ontario N2V 1C5 Canada Testing Page 9 of 17

12 Nutek Corporation 1001 Whipple Road Hayward CA Rhythmia Medical Inc. 111 S. Bedford Street Suite 205 Burlington MA Rhythmia Medical Inc. 125 Cambridgepark Drive Cambridge MA E beam Sterilization Design Design Page 10 of 17

13 Stellartech Research Corp. 560 Cottonwood Drive Milipitas CA Sterigenics U.S. Inc South Quincy Street Willowbrook Illinois Sterigenics Withers Cove Park Dr. Charlotte NC ETO Sterilization Gamma Sterilization Page 11 of 17

14 Sterigenics 84 Park Road Queensbury NY STERIS ISOMEDIX Services, Inc 7685 Saint Andrews Avenue San Diego California STERIS Isomedix Services 1880 Industrial Drive Libertyville Illinois ETO Sterilization ETO Sterilization Gamma Sterilization Page 12 of 17

15 STERIS Isomedix Services 3459 South Clinton Ave. South Plainfield New Jersey Steris Isomedix Services th Avenue NW Minneapolis Minnesota Surmodics 9924 West 74th Street Eden Prairie Minnesota ETO Sterilization Sterilization Page 13 of 17

16 Synergy Health AST, LLC 500 West 4th Street Lima OH Synergy Health AST, LLC 9020 Activity Road, Suite D San Diego CA Synergy Health AST, SLR Calle 4; Avenida 0 Coyol Free Zone Alajuela Costa Rica E beam Sterilization E beam Sterilization E beam Sterilization Page 14 of 17

17 Synergy Health AST, SRL B13.1 Street 4, Avenue 1 El Coyol Free Zone El Coyol Alajeula Costa Rica Synergy Health AST, Venlo Faunalaan 38 Venlo 5928 RZ Netherlands Synergy Health Ireland LTD (Synergy Health - AST - Ireland) IDA Business & Technology Park Sragh Tullamore Co. Offaly Ireland ETO Sterilization ETO Sterilization ETO Sterilization Irradiation Sterilization Page 15 of 17

18 Synergy Health Westport Ltd (Synergy Health - AST - Westport) Lodge Road Westport, County Mayo Ireland TechDevice Costa Rica Limitada 400m East Holcim, Zona Industrial FlexiPark, Bodega G6 San Rafael Costa Rica Teleflex Medical Unit 7, 8, & 9 Annacotty Business Park Annacotty Limerick Ireland Gamma Sterilization Page 16 of 17

19 Venusa de Mexico S.A. de C.V. A Lake Region Medical Company 1525 Hertz Street Industrial Park J. Bermudez of Cd. Juarez Chihuahua CP Mexico Page 17 of 17

20 Certificate History Date 30 June October January March May Reference Number Action First issue with, 300 Boston Scientific Way,,, as Legal r. Mirror certificate to CE Addition of Synergy Health in Costa Rica as significant subcontractor for ETO sterilization. Notified Body transfer of various families of devices primarily in the endoscopic and urological areas associated with the Spencer, IN and the Coyol, Costa Rica facilities. Update to the certificate scope to add these device families. Addition of various significant subcontractors involved in the manufacturing and sterilization. Addition of Endoscopes, Biliary Devices, and Inflation Devices to the scope of the certification. Addition of Sterigenics in Queensbury, NY and updates to the services supplied by Sterigenics in Charlotte, NC and the Boston Scientific Heredia facility. "" to Maple Grove location; remove activity "Design" from Plymouth location. Add Bard Electrophysiology, Lowell, as subcontractor for Design. Add Creation Technologies as subcontractor for. Add Dedicated Computing as Crucial Supplier. Add "Recording & Amplifier Systems, Including Software" to certification scope. Page 1 of 3 Validity of this certificate is conditional on the quality system being maintained to the requirements of the Directive as demonstrated through the required surveillance activities of the Notified Body. This approval excludes all products designed and/or manufactured by a third party on behalf of the company named on this certificate, unless specifically agreed with BSI. This certificate was issued electronically and is bound by the conditions of the contract.

21 Certificate History Date 25 June July August October November November January Reference Number Action Notified Body Transfer of Entry Needles, Torque Vise, and Vascular Dilators into BSI as part of existing certificate scope. Addition of tissue and thrombus removal devices to the certification scope for the Bayer devices as part of the quality system integration. Addition of significant subcontractor Minnetronix for the manufacture of consoles. Extension to scope to add Diagnostic Mapping, Pacing, and Recording Catheters and Umbilical Cable and the related significant subcontractors Update to scope to remove Magnetic to include other types of Exchange Devices. Addition of significant subcontractor FMD. Co., Ltd. for the services of design and manufacture. Addition of Boston Scientific location in Galway, Ireland as a significant subcontractor for manufacturing. Addition of BSC Minneapolis sites for Design and as part of quality system integration of tissue and thrombus removal devices. Update to scope to add Cables as part of Legal Manufacturing change for the Bard EP integration. Addition of significant subcontractor TechDevice Costa Rica for the services of manufacture. Page 2 of 3 Validity of this certificate is conditional on the quality system being maintained to the requirements of the Directive as demonstrated through the required surveillance activities of the Notified Body. This approval excludes all products designed and/or manufactured by a third party on behalf of the company named on this certificate, unless specifically agreed with BSI. This certificate was issued electronically and is bound by the conditions of the contract.

22 Certificate History Date 08 April April June August Reference Number Action Addition of subcontractor Availmed S.A. de C.V., Col. Cd. Industrial (Otay) for the manufacture of Expo and Impulse angiographic catheters. Removal of ATEK Medical from list of subcontractors, name change of subcontractor from Accellent to Venusa de Mexico, and the addition of Boston Scientific Limited for the services of manufacture and labeling. Addition of Bard Glens Falls Operation as subcontractor for. Extension to Scope to include Mapping Systems, and addition of subcontractors BSC St. Paul for Design and and Creation Technologies for. Page 3 of 3 Validity of this certificate is conditional on the quality system being maintained to the requirements of the Directive as demonstrated through the required surveillance activities of the Notified Body. This approval excludes all products designed and/or manufactured by a third party on behalf of the company named on this certificate, unless specifically agreed with BSI. This certificate was issued electronically and is bound by the conditions of the contract.