Quality management system
and legal manufacturer status

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Abgabetermin: 18.07.2020

Auftragsart: Dienstleistung

Archiv | 04.07.2020 |

We are developing a class I medical device software under EU MDD. The fastest route to market is to outsource the QMS and legal manufacturer (LM) status. We are looking for a trusted partner to take over the regulatory burden.

 

Scope

We need:

  • A lean QMS, which also needs to be set up

  • A partner to take over the status of legal manufacturer

  • All regulatory requirements fulfilled to be CE marked by May 26th 2021

We will be providing clinical studies. The software development and documentation will be performed by third parties (our software development partners will be ISO13485 certified). The Pipra team will support with product-related input and provide clinical knowledge for preparing the technical documentation.

 

Expectation

We expect to need around 240 hours of expert time to fulfil all regulatory obligations. The cost for the legal manufacturer status should include costs for maintenance, for complaint handling and post-market surveillance activities.

 

Further information

  • more detailed information is available upon signing an NDA, please get in touch

Evaluation criteria

The evaluation and final decision will be made by an independent external specialist.

The evaluation will be based on cost vs quality. Quality in this particular sense is to get our medical device software CE marked before 26th May 2021, while fulfilling all regulatory obligations and without losing control over our product. A proxy for this is experience, reputation and flexibility.

The evaluation will thus be based on the following criteria: Experience & success with similar projects (40%) + Reputation (20%) + Flexibility (40%) divided by cost in CHF.

 

Cost: The cost for a total of four years will be calculated. Typically, there will be a setup cost (year 1) and annual costs (year 2+). For each quote, we will calculate the average annual cost for four years (2020-2024, because we expect to recertify under MDR in 2024).

 

Reputation: How often has this company been recommended to us?

1/5 no recommendations
2/5 recommended at least once
3/5 good local reputation (local recommendations)
4/5 good global reputation (global recommendations)
+1 if the person recommending has worked on a project with them

 

Flexibility:

The requirement for hiring an extra employee = score of 1/5
Otherwise, the score is 3/5
+1 points for flexible hours (=if we do more, it gets cheaper)
+1 point for simplicity to switch to becoming our own LM
penalties if it is contractually difficult to switch to become our own LM

 

Experience and success with similar projects

Similar projects are defined in the following areas

  • Startups

  • Software projects in medtech

  • AI projects

1/5 no experience
2/5 experience with one area
3/5 experience with two areas
4/5 experience with all three areas
+1 point if there's a specialisation on either of the three areas

HINWEISE: Die Beantwortung einer Kontaktaufnahme, im Besonderen bei einer verdeckten Ausschreibung obliegt dem ausschreibenden Anbieter.