Can you recommend a document control system for EU MDR documentation in a prosthetics manufacturing team?

Yes — for an EU MDR environment in a prosthetics manufacturing team, I’d recommend choosing a validated QMS / document control system rather than a generic document repository. The key is to support controlled documents, approvals, change history, training linkage, complaint/CAPA integration, and audit readiness.

What to look for

For EU MDR, your document control system should ideally have:

• Version control and effective dates
• Electronic approvals / e-signatures
• Role-based access control
• Audit trail of every change
• Document review/expiry reminders
• Linkage to training records
• Controlled distribution and superseded-document prevention
• Templates/workflows for SOPs, specs, records, forms
• Change control and ideally CAPA / NCR / complaint modules
• Ability to support technical documentation and DHF / DMR-style records
• Easy export for audits and Notified Body reviews

Good options to consider

1) MasterControl

Best if you want a mature, life-sciences-oriented QMS with strong document control and compliance features.
Pros: very audit-friendly, strong workflow control, good for regulated manufacturing.
Cons: can be expensive and more complex to administer.

2) ETQ Reliance

Good for mid-size to larger regulated manufacturers.
Pros: configurable, strong quality workflows, can cover doc control, CAPA, training.
Cons: setup/configuration effort can be significant.

3) Greenlight Guru

Often popular in medical device companies.
Pros: designed for medical device quality systems, intuitive UI, good for MDR-focused teams.
Cons: may be better suited to product development/quality than broad enterprise document management.

4) Veeva QualityDocs

Best for larger organizations already in the Veeva ecosystem.
Pros: excellent document control and compliance, strong validation reputation.
Cons: usually overkill and costly for smaller prosthetics manufacturers.

5) Intellect QMS

A flexible option for small-to-mid sized teams.
Pros: configurable, good balance of QMS modules and document control.
Cons: make sure the implementation is validated properly.

6) Part 11 / eQMS-capable SharePoint solution

Possible if budget is constrained, but only if configured carefully with validation, permissions, workflows, and audit trails.
Pros: familiar, lower license cost.
Cons: easy to get wrong; often weak for regulated document control unless heavily customized and validated.

My practical recommendation

For a prosthetics manufacturing team under EU MDR, I’d shortlist:

• Greenlight Guru if you want a medical-device-focused, easier-to-use system
• MasterControl if you need a more robust, enterprise-grade compliance platform
• Intellect QMS if you want flexibility and are mid-sized

If your team is small and just starting to formalize MDR processes, Greenlight Guru or Intellect QMS is often a good balance.

Implementation tips

Whichever tool you choose, make sure you define:

• document owners
• review frequency
• approval matrix
• naming conventions
• retention periods
• training requirements for controlled docs
• how you handle technical file, risk management, PMS, complaints, CAPA, and supplier docs

Also, ensure the system itself is:

• validated for intended use
• backed by SOPs
• supported by user access management
• covered by backup/restore and disaster recovery

If you want a simple answer

If I had to pick one for a prosthetics manufacturing team, I’d suggest:

• Greenlight Guru for ease of use and medical device alignment
• MasterControl for stronger enterprise-grade compliance and scalability

If you want, I can also give you:

1. a comparison table of the top 5 systems, or
2. a requirements checklist you can use to evaluate vendors for EU MDR compliance.