Manufacturers

EU Manufacturer

Publish Declarations of Conformity and Documents online

EU Manufacturer

Economic Operator Requirement Procedure

Section description goes here

Identify Importer, Distributor

Section description goes here

Identify Role for the Company

Section description goes here

Product Label Responsibilities

Section description goes here

Facility Requirements

Section description goes here

Contract / Agreement

Section description goes here

EUDAMED Registration

Section description goes here

Traceability

Section description goes here

Train Distributors on Responsibilities

Section description goes here

Closed Loop Post Market Surveillance

Section description goes here

Setup Receiving Inspection Requirements

Section description goes here

Evaluate/Monitor Distributor

Section description goes here

QMS Transition from MDD to MDR

Section description goes here

EU Manufacturer Starter Packs

Publish Declarations of Conformity and Documents online

Starter Packs:
Document bundles organized to help to get quality professionals get started

Initial Steps for Remediation – Product Detail

$650.00

Post Market Surveillance Remediation – Product Detail

$1,200.00

Risk Management Remediation – Product Detail

$1,200.00

EU Manufacturer Starter Pack Bundle – Product Detail

$2,800.00

Non-EU Manufacturer

Publish Declarations of Conformity and Documents online

Non-EU Manufacturer

Economic Operator Requirement Procedure

Section description goes here

Identify Authorized Representative, Importer, Distributor

Section description goes here

Identify Role for the Company

Section description goes here

Product Label Responsibilities

Section description goes here

Facility Requirements

Section description goes here

Contract / Agreement

Section description goes here

EUDAMED Registration

Section description goes here

Traceability

Section description goes here

Train Importers and Distributors on Responsibilities

Section description goes here

Closed Loop Post Market Surveillance

Section description goes here

Setup Receiving Inspection Requirements

Section description goes here

Evaluate/Monitor Distributor

Section description goes here

QMS Transition from MDD to MDR

Section description goes here

Non-EU Manufacturer Starter Packs

Publish Declarations of Conformity and Documents online

Starter Packs:
Document bundles organized to help to get quality professionals get started

Initial Steps for Remediation – Product Detail

$650.00

Post Market Surveillance Remediation – Product Detail

$1,200.00

Risk Management Remediation – Product Detail

$1,200.00

Non-EU Manufacturer Starter Pack Bundle – Product Detail

$2,800.00

EU Manufacturer

Economic Operator Requirement Procedure

Economic Operator Procedure, EU Manufacturer – $250

Identify Importer, Distributor

Identify Role for the Company

Job Descriptions/Competency with PRRC and EUDAMED roles define-MDR – $150

Product Label Responsibilities

Facility Requirements

Contract / Agreement

Business Profile – $150

Distributor Supply and Quality Agreement-MDR – $150

EUDAMED Registration

Traceability

Train Distributors on Responsibilities

Training, Distributors and Importer Responsibilities – $300

Closed Loop Post Market Surveillance

Setup Receiving Inspection Requirements

Evaluate/Monitor Distributor

QMS Transition from MDD to MDR

Starter Packs: Document bundles organized to help to get quality professionals get started

Initial Steps for Remediation

Post Market Surveillance Remediation

Risk Management Remediation

Bundle of Starter Packs

Non-EU Manufacturer

Economic Operator Requirement Procedure

Economic Operator Procedure, Non-EU Manufacturer – $250

Identify Authorized Representative, Importer, Distributor

Identify Role for the Company

Job Descriptions/Competency with PRRC and EUDAMED roles define-MDR – $150

Product Label Responsibilities

Facility Requirements

Contract / Agreement

Business Profile – $150

Distributor Supply and Quality Agreement-MDR – $150

EUDAMED Registration

Traceability

Train Importers and Distributors on Responsibilities

Training, Distributors and Importer Responsibilities – $300

Closed Loop Post Market Surveillance

Setup Receiving Inspection Requirements

Evaluate/Monitor Distributor

QMS Transition from MDD to MDR

Starter Packs: Document bundles organized to help to get quality professionals get started

Initial Steps for Remediation

Post Market Surveillance Remediation

Risk Management Remediation

Bundle of Starter Packs

Starter Packs:
Document bundles organized to help to get quality professionals get started

Starter Packs:
Document bundles organized to help to get quality professionals get started