ABOUT STERIPACK MEDICAL DEVICES CONTRACT MANUFACTURING PHARMACEUTICAL PRODUCTS CONTRACT PACKING DIAGNOSTIC PRODUCTS CONTACT US Regulatory Services The experts at the SteriPack Group stay up-to-date with the latest regulations and standards, to provide Customers with the most relevant and reliable medical device guidance. When introducing a new product to the market, Customers can choose to oversee the relevant regulatory requirements or hand responsibility to CMO. SteriPack offer expertise and advice on localised medical device regulations during the approval of products, at every stage of their development. The SteriPack Group is qualified to advise on: Contract regulatory advice: CE marking Device regulation 510k submission Consulting services for sterilisation and test methods FDA regulations: FDA regulatory strategy FDA device Classification US FDA 510(k) preparation UDI compliance consulting FDA QSR implementation US agent representation EU Regulations: Device registration European CE marking Strategy for Medical Devices CE technical file or design dossier compilation and review European medical device classification European authorized representative for medical device companies QMS Compliance: ISO 13485 audits for medical Device ISO 13485 consulting and implementation for medical device manufacturers ISO 13485:2016 consulting and gap analysis QMS compliance for startup medical device companies Short term or part-time medical device QA/RA outsourcing Medical device gap, internal, pre-certification and supplier QMS audits ISO 14971 risk management consulting for medical device Testing and Validation: Material and chemical characterization testing for medical devices Biocompatibility testing ISO 10993 Extractables & leachables ISO 10993 Clinical Evaluation (MDR)/Clinical literature review Gamma, e-beam, X-ray and EO processes validation CT scanning and measurement services Software validation (GAMP5) Sealing process validation Sterilie Barier System validation SteriPack's expertise: CE marking of medical devices up to Class IIb and 510K submission. You may be interested Clean room Injection Moulding MORE > Medical Devices Design & Development MORE > Medical Devices Assembly MORE > © 2021 by SteriPackGroup.com CAREERS CONTACT US BLOG PRIVACY POLICY GENERAL TERMS & CONDITIONS

ABOUT STERIPACK MEDICAL DEVICES CONTRACT MANUFACTURING PHARMACEUTICAL PRODUCTS CONTRACT PACKING DIAGNOSTIC PRODUCTS CONTACT US IFU Below you will find links to all SteriPack IFU’s: Sterile Nasopharyngeal Swab Product Insert IFU Sterile Flocked Swab IFU Safety Needles IFU © 2021 by SteriPackGroup.com CAREERS CONTACT US BLOG PRIVACY POLICY GENERAL TERMS & CONDITIONS