Product Roadmap

The clearer the view ahead of your company, the easier it becomes to follow the company’s set path towards the achievement of its goals. Where medical devices are concerned, often it’s the challenges, requirements, and action items are heavily imbued in regulatory affairs (RA) and quality assurance (QA) and innovators would benefit if they extended their attention towards these areas. The following roadmap will help you understand the road that medical device companies face and its demands.

Select a stage:

Kick Start

QMS

CE

FDA

Kick Start

Steps in stageStep DescriptionEffort (M/D)Deliverables
ContractQuote1
NDA1
Establish Pre - Project StatusGap Analysis2-3
Project PlanWork Flow 0.5
Assign Resources0.5
Kick off meeting 0.25
RA Strategy RA plan 10-12
Approve RA Strategy1

QMS

Steps in stageStep DescriptionEffort (M/D)Deliverables
QA systemDefine QMS Scope -Define the ISO implementation5-10Quality policy & quality manual
Processes & procedures - Align existing / ongoing processes with the ISO requirements & consistency in quality is being preserved 36-48All mandatory documentation required by ISO 13485:2016 on top of the above
Internal Training -Making sure all employees are aligned with the defined & documented QMS processes1-4Training documentation
Management review - Making sure management is aligned with the QMS and its requirements 1-2Management review presentation
Communication with certification body 3-4
Kick off meeting 0.25
Audit Performing Internal / external audits4-6Internal audit documentation
MaintenanceProcess maintenanceOngoing
Internal / External audit Ongoing
Communication with certification body Ongoing

CE

Steps in stageStep DescriptionEffort (M/D)Deliverables
Device Classification Determine device’s properties 1-2Classification of device according to European directive
Technical file / design dossier Provide a detailed information on the device 3-5Technical file / design dossier
Prepare submission documentation Prepare submission documentation60-120Prepare submission documentation
Clin
Appoint a Notified body Aside from class | The NB will audit the QMS and submission docs2-5

Submission form
NB Audit – a review of internal processes and procedures to ensure conformity with European directive 2-5Audit documentations
MaintenanceProcess maintenanceOngoing
Internal / External audit Ongoing
Communication with certification body Ongoing

FDA

Steps in stageStep DescriptionEffort (M/D)Deliverables
Device Classification Determine device’s properties 1-2Classification of device according to European directive
Technical file / design dossier Provide a detailed information on the device 3-5Technical file / design dossier
Prepare submission documentation Prepare submission documentation60-120Prepare submission documentation
Clin
Appoint a Notified body Aside from class | The NB will audit the QMS and submission docs2-5

Submission form
NB Audit – a review of internal processes and procedures to ensure conformity with European directive 2-5Audit documentations
MaintenanceProcess maintenanceOngoing
Internal / External audit Ongoing
Communication with certification body Ongoing

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