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A.P. Lyon
MDSAP-Ready ISO 13485 QMS — Manufacturing Plus | ISO 13485, FDA QMSR & MDSAP cover

MDSAP-Ready ISO 13485 QMS — Manufacturing Plus | ISO 13485, FDA QMSR & MDSAP

$3,860.00Price

One complete quality system, ready for the Medical Device Single Audit Program. This is the full ISO 13485 QMS Manufacturing Plus package (ISO 13485:2016 + FDA QMSR) with the MDSAP integration already done. There are no procedures to swap or merge: the MDSAP requirements of all five participating jurisdictions are built into the system you download.


What you receive


  • The complete ISO 13485 QMS Manufacturing Plus system: quality manual, procedures and forms for design, manufacturing, sterilization, purchasing, complaints, CAPA, post-market surveillance and more

  • 33 procedures updated for MDSAP, each with a section setting out the US, Canadian, Australian, Brazilian and Japanese requirements that apply to it

  • New MDSAP procedures: MDSAP Program and Audit Readiness; Marketing Authorization and Facility Registration; MDSAP Adverse Event and Advisory Notice Reporting, with deadline tables for all five jurisdictions; Servicing.

  • MDSAP annex to the quality manual for your certificate scope, markets and regulatory partners

  • Seven new forms, including a Marketing Authorization Register, a Regulatory Report Decision and Timeline Log, a Complaint Reporting Decision Tree, a Regulatory Partner Quality Agreement and a 90-task MDSAP Audit Readiness Checklist in Excel

  • Updated master document list with an MDSAP cross-reference


Jurisdictions covered


  • United States: FDA QMSR, 21 CFR 803, 806, 807, 814, 830

  • Canada: Medical Devices Regulations SOR/98-282

  • Australia: Therapeutic Goods (Medical Devices) Regulations 2002

  • Brazil: RDC ANVISA 665/2022, 67/2009, 551/2021, 751/2022, 848/2024

  • Japan: PMD Act and MHLW Ministerial Ordinance No. 169


Microsoft Word and Excel files. Delivered as one integrated system, ready to issue through your document control.


Why A.P. Lyon


Written and maintained by Aaron Lyon, a former Senior Director of Regulatory Affairs whose documents have been used in FDA, notified-body and ISO certification audits in 45 countries. These are working documents, kept current and expert-backed.


Scope


Documents to support ISO 13485 and MDSAP certification. They do not certify your QMS or guarantee an audit outcome, and are not legal advice.

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