Quality & Regulatory Compliance
Everything your procurement and quality teams need to evaluate GNM Precision with confidence. Documentation is available on request, and you deal with an accountable Nordic partner throughout.
For the teams who buy surgical instruments, regulatory compliance is not a detail. It is the baseline. GNM Precision comes from Go North Medical, whose core business is neurosurgery and Class III implantable devices, so regulatory discipline is not new to us. We hold single-use laparoscopy to the same standard.
Below is how we evidence that discipline, and the documentation we can put in front of your quality and procurement teams.
CE Marking
Every device we supply is CE marked in accordance with the applicable EU medical device regulations. The Declaration of Conformity for any product is available to your regulatory team on request.
ISO 13485 Quality Management
Our products are manufactured under a certified ISO 13485 quality management system. We qualify every manufacturing partner against our own specifications, monitor quality performance, and verify each batch before it is released to the Nordic market.
Supplied Sterile, Single-Use
Instruments are supplied sterile and single-use, removing the reprocessing variability and cross-contamination risk of reusable devices. Sterility status and shelf life are stated clearly on every pack.
Identification & Traceability
Every product carries a GTIN for unambiguous identification, with lot and batch traceability from manufacture through to delivery. This supports UDI requirements and gives your stores and recall processes a clean audit trail.
Biocompatibility & Safety
Patient-contact materials are evaluated for biocompatibility as part of the conformity assessment for each device. Evaluation summaries are available to your quality team on request.
Post-Market Surveillance & Vigilance
We operate a documented post-market surveillance and vigilance process. Any field safety issue is handled through a controlled recall and field-safety-notice procedure, coordinated from a single Nordic point of contact.
Documentation That Passes Procurement
Tenders and supplier onboarding live or die on paperwork. We assemble the pack your process needs, so you are not waiting on an overseas manufacturer to answer.
Tell us what your tender requires and we will put the file together.
- EC Declaration of Conformity
- CE certificates
- ISO 13485 certificate
- Instructions for Use (IFU)
- Sterilisation validation summary
- Biocompatibility summary
- Product specifications and GTIN lists
- Traceability and lot documentation
An Accountable Nordic Partner
GNM Precision is a Swedish company. We are your local, accountable point of contact for regulatory documentation, product complaints, and post-market support. You are dealing with a serious medical-device team on your side of the border, not chasing a supplier several time zones away.
Need our compliance documentation?
Tell us which certificates or declarations your tender or onboarding process requires and we will send them across.
Request Documentation