Our experienced team has for years done documentation for companies who are manufacturers of medical devices /surgical instruments. We provide Quality-Management-Systems for meeting legal and normative requirements. For manufacturers of medical devices / surgical instruments class I (including Is, Im, and new for MDR class Ir), IIa, and IIb we offer the following services: Implementation DIN EN ISO 13485 and the EU-Regulation 2017/745 MDR and 21 CFR 820 QSR Creating QM-Systems with procedural instructions and work instructions Technical Documentation Clinical evaluation Risk Management / Risk Analysis Essential Safety and Performance Requirements Validation of processes UDI-labeling Consulting for Regulatory Affairs Internal audits and external supplier audits Accompaniment and support with inspections by authorities and Audits by notified bodies Communication with authorities
Sweden
Length: 240 mm Compliant with Regulation MDR (EU) 2017/745, EN 455, PSA Regulation (EU) 2016/425, EN ISO 21420, EN 374 AQL 1.5 PSA Category III: Waterproof protective gloves against chemical hazards Medical product class i 1 pack = 100 gloves // 10 packs = 1 box // 84 boxes = 1 pallet
Request for a quoteFrance
• FFP1 half mask, non-reusable (NR), duckbill type. • Customisable. • Total back length: 245 mm, standard size. • This FFP1 mask for personal respiratory protection is single use & non-sterile. • PRISM masks are manufactured on our production line in Frontignan in the Hérault region of France & meet the recommended European and French standards. • Double certification : - NF EN 149+A1 2009 ; -14683 + AC 2019. • PRISM carries out quality controls as it produces. • COMPOSITION 1/ A "duckbill" mask organised in several layers : - outer layer in non-woven polypropylene (= spunbond) ; - 2 intermediate layers ensure filtration with meltblown fabric. 2/ A double nose bar to adjust the mask to the shape of the nose & to reduce fogging of the glasses ; 3/ A double flat elastic band (manual separation) to fix the mask to the face.
Request for a quoteNetherlands
Accu Chek Instant test strips For determining blood sugar Suitable for self-application Suitable for the following blood glucose meters: Accu-Check® Instant Accu-Check® Instant S
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The calibrated, precise and medical scales from KERN & SOHN offer the highest precision and reliability for various applications in the medical and veterinary sector. Discover our comprehensive product range, which has been specially developed to meet the highest requirements in the healthcare sector, e.g. in hospitals, doctors' surgeries, nursing homes and pharmacies as well as for midwives.
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