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
Steps in stage | Step Description | Effort (M/D) | Deliverables |
---|---|---|---|
Contract | Quote | 1 | |
NDA | 1 | ||
Establish Pre - Project Status | Gap Analysis | 2-3 | |
Project Plan | Work Flow | 0.5 | |
Assign Resources | 0.5 | ||
Kick off meeting | 0.25 | ||
RA Strategy | RA plan | 10-12 | |
Approve RA Strategy | 1 |
QMS
Steps in stage | Step Description | Effort (M/D) | Deliverables |
---|---|---|---|
QA system | Define QMS Scope -Define the ISO implementation | 5-10 | Quality policy & quality manual |
Processes & procedures - Align existing / ongoing processes with the ISO requirements & consistency in quality is being preserved | 36-48 | All 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 processes | 1-4 | Training documentation | |
Management review - Making sure management is aligned with the QMS and its requirements | 1-2 | Management review presentation | |
Communication with certification body | 3-4 | ||
Kick off meeting | 0.25 | ||
Audit | Performing Internal / external audits | 4-6 | Internal audit documentation |
Maintenance | Process maintenance | Ongoing | |
Internal / External audit | Ongoing | ||
Communication with certification body | Ongoing |
CE
Steps in stage | Step Description | Effort (M/D) | Deliverables |
---|---|---|---|
Device Classification | Determine device’s properties | 1-2 | Classification of device according to European directive |
Technical file / design dossier | Provide a detailed information on the device | 3-5 | Technical file / design dossier |
Prepare submission documentation | Prepare submission documentation | 60-120 | Prepare submission documentation |
Clin | |||
Appoint a Notified body | Aside from class | The NB will audit the QMS and submission docs | 2-5 | Submission form |
NB Audit – a review of internal processes and procedures to ensure conformity with European directive | 2-5 | Audit documentations | |
Maintenance | Process maintenance | Ongoing | |
Internal / External audit | Ongoing | ||
Communication with certification body | Ongoing |
FDA
Steps in stage | Step Description | Effort (M/D) | Deliverables |
---|---|---|---|
Device Classification | Determine device’s properties | 1-2 | Classification of device according to European directive |
Technical file / design dossier | Provide a detailed information on the device | 3-5 | Technical file / design dossier |
Prepare submission documentation | Prepare submission documentation | 60-120 | Prepare submission documentation |
Clin | |||
Appoint a Notified body | Aside from class | The NB will audit the QMS and submission docs | 2-5 | Submission form |
NB Audit – a review of internal processes and procedures to ensure conformity with European directive | 2-5 | Audit documentations | |
Maintenance | Process maintenance | Ongoing | |
Internal / External audit | Ongoing | ||
Communication with certification body | Ongoing |