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FDA QSR820

Getting into US Market

For foreign manufacturers, Operator Registration, Medical Device Listing, US-agent, Official Correspondent, and cGMP, are required before getting into the US market.

For high-risk products, Pre-Market Application (PMA) is required.

FDA-cGMP-QSR820 factory inspection

cGMP, means current Good Manufacturing Practices.

The requirements of FDA, such as MDR, System of Adverse Event Reporting, CAPA are much more tougher than ISO13485.

For example: To avoid serious risks, resulting in Warning letter, Recall, Rejection by US-market, manufacturers should establish quality system to guarantee product quality according to FDA-cGMP-QSR820.

QSR Factory Inspection Prepare Procedure

I．Gap analysis

? Review 15 Subparts A-O

? Current QS, Organization

? Analysis of current QS (compliance, sufficiency, validity) 

II．QSR Working Group

? Management representative, Team member

? Responsibility,

III．Structure scheme

? File structure

? Quality manual structure

? Program files list

? Records list

? Guide book list

? Files docking

IV．Files Integration

? Quality manual integration

? Program files integration

V．Operation Training

? QSR subpart A-O explaining

? DMR、DHR、DHF、MDR、SOP、Design transfer explaining

? Training assessment after Files Integration

VI．Detailed Guidance

? QSR Operation, Correction, Consummate

? QSR Management Responsibility, Quality Auditing

? QSR Staff

? QSR Management: Design/Files/Purchase

? QSR Identification, tracing, production management

? QSR Inspection, Testing, Testing equipment

? QSR Process validation

? QSR Check before acceptance for products:

Upcoming,/Producing,/Produced

? QSR Unqualified Products/CAPA

? QSR Label and package

?Manufacture/Storage/Distribution/Installation/Reparation

? QSR Statistical Techniques 

VII．Record Check

? General requirement

? Record: DMR, DHR, 

VIII．Pre-audit

? Pre-audit plan, performance

? Non-confirming Reporting,

? Analysis of No-confirming

? Corrective and preventive actions, Validation Actions

IX．Inspection Accompany

? Matters needing attention

? Experience, technique

X．Qualified

? CAPA, evidence

? Qualified

What We Do?

--Gap analysis audit

--Pre-assessment audit

--Full or partial internal audit

--Subcontractor or supplier audit

--Document and records control

--Training on regulatory requirements and internal procedures

--Design and development

--Risk management

--Software development (if applicable)

--Supplier evaluation

--Control of measurement equipment

Why Jiushun Management?

Jiushun Management, focused on Medical Device Registration, Certification for 20 years, provided high quality service for more than 5,000 global customers.

The MD industry focus degrees, regulatory familiarity, and rich experience, determine our high efficiency and professionalism.

Our professional technical support, from the early regulations, processes guidance, documentation preparation, to testing assistance, review tracking, as well as years of MD industry resource integration, will greatly shorten the period of your product approval, and well practice our principle "Jiushun Management, create value for you. ".