Reproduce registration work

The keyword pathway is oft said in regulatory work. Actually depending on product type and market the tactic of registration varies. However for one product type in one manufacturer, the pathway can be reproduced if the former registration is well recoded.

 

In this article we dedicated to reproduce registration work of medical device (IVD) for the global market

 

1. Consolidated folder of technical documentation

 

The good example of technical document of medical device is table of content by IMDRF. Regulatory affairs manager should make a consolidated folder from preparation to final approval so third person can without RA knowledge understand what is final submitted.

 

NO-GO:

• A difficult and long folder or document name

• More than 5 levels of folder as labyrinth

• Not put old document in archive

 

Challenge:

• Integrate deficiency reply in consolidated folder

• Match to design history file

 

2. Record critical communication (email, meeting)

 

Theoretically all communications should be recorded. However only critical communication matters as in one meeting, a bundle submission is decided than single submission of medical device. The critical communication should be categorised and summarised. So in x year if “physical testing” is searched, all emails and notes can be found led by main decision than detailed email content.

 

No-Go:

• No topic as name of email

• Record email or meeting protocol with obsolete decision

• No plain language or too short formulation

 

Challenge:

• Common understanding of language

 

3. Trace milestone tasks

 

As said before critical issues as testing, clinical trial, tactic decision matter because it takes time, cst and effort. It must be as treasure recorded as milestone achievement for the whole lifecycle of country specific registration. Another ignored point is deficiency reply. It must be traced and reproduced to avoid same deficiency in next registration.

 

No-Go:

• Only chronological note at milestone meeting

• No cluster of traced task

 

Challenge:

• Easy traceability with ID or keyword

 

4. Exchange in team work

 

Without exchange in team, company and with extern partners, misunderstanding will be battled and important tasks are forgotten. Regular ideally face to face meeting to exchange is best project meeting. The task must be addressed with deadline.

 

No-Go:

• Only email communication

• No dig-deeper

 

Challenge:

• Transparent communication with clear tasks

 

5. Keen to writing uncontrolled instruction, checklist, template

 

The company has thousands technical documents undergoing release protocol. However in every firm active writing of uncontrolled instruction, checklist, template is missing. Why uncontrolled, because colleague can easily revise benefiting from daily regulatory work.

 

The example could be:

• Instruction of registering UDI in US

• Instruction of Appling free ales certificate

• Checklist of product release after approval

• Template of oft used material certificate

Challenge:

• Update and desolate e.g. instruction

 

What can we support

 

In our personal workshop in DACH region, our coach will have an interactive workshop to reproduce customer tailored success. At end each participant will find solution to optimise work in terms of registration of medical device.

 

​