01Initial assessment
Gap assessment report
What is missing against GOST ISO 13485 requirements: processes, documents and records.
Outcome: assessment report and audit preparation plan
Quality management system
QMS and ISO 13485 for medical devices
We prepare medical device manufacturers for GOST ISO 13485 certification and manufacturing inspection. We assess what is in place, develop procedures and record forms for actual operations rather than the shelf, and support the audit through to closure of findings.
A description of the devices and facility is enough for the first conversation.
- 450+ projects of any complexity
- Direct contracts with laboratories
- One expert from start to finish
What you receive
A QMS that works beyond the document folder
Three stages, from an initial assessment to closed audit findings.
02Documents
A QMS tailored to your processes
A quality manual, procedures, instructions and record forms reflecting how your business actually works.
Outcome: QMS document set
03Audit
Preparation and findings
Staff preparation, internal audit and assistance in closing the certification body's findings.
Outcome: closed audit findings
How QMS implementation works
The scope depends on process readiness and the number of facilities. A typical route is shown below.
01
Initial assessment
We review on-site processes, documents and records.
Outcome: a list of gaps02
Documents
We write procedures and forms for actual operations.
Staff training runs in parallel03
Internal audit
We check that the system works in practice.
We resolve findings before the external audit04
Certification
We support the certification body's audit.
Outcome: ISO 13485 certificateWhy clients choose us
Registration without detours and lost months
We do not sell template packages. Every project starts with analyzing the device, so the documents pass the expert review and cause no problems after registration.
We read the dossier like an expert
Our team includes test engineers. They find discrepancies before submission, not after Roszdravnadzor remarks.
We write documentation from scratch
No specifications or operating manual? We will develop them. Have them but with errors? We will refine them so that everything matches.
One expert from start to finish
One specialist runs your project. They coordinate with the manufacturer and laboratories and are always available.
Devices of any complexity
From dressings to anesthesia units, X-ray equipment and implants. More than 450 projects in 10 years.
We start by evaluating existing processes and documentation. We then identify missing documents, necessary changes and the stages of audit preparation.
Scope of work
- Assessing the current QMS and reviewing company documentation.
- Describing development, purchasing, manufacturing, inspection and nonconformity processes within the agreed scope.
- Preparing procedures, instructions and record forms with reference to ISO 13485 and GOST ISO 13485.
- Developing traceability, document control and quality records.
- Audit preparation and assistance with findings.
Preparing for certification and inspection
First, we clarify the objective: build a QMS from scratch, undergo a certification audit or prepare for a manufacturing inspection as part of registration. This determines the scope. The certification body decides whether to issue the certificate. Our role is to help the audit proceed without critical findings.
What to send for an assessment
A brief description of the devices, manufacturing facilities, operations performed and existing QMS documents. If an audit has already taken place, its report and findings are useful.
Work stages
The scope depends on QMS readiness, the number of facilities and process complexity. After assessment, you will receive a plan with deliverables for each stage.
QMS work is connected with medical device registration, projects under EAEU rules and manufacturing localization.
Trusted by
Chosen by those who cannot afford a mistake in the dossier
Developers of devices for military medicine, defense enterprises, Russian plants and manufacturers from China, Türkiye, Korea and Germany. Below are our partners and signed and sealed letters of appreciation.
Appreciation from the Burdenko Main Military Clinical Hospitalfor professionalism and contribution to the domestic medical industry
Talk at the Military Medicine of the 21st Century conferencethe conference is organized by the S. M. Kirov Military Medical Academy
Letters from VIKor, SigmaPharm, Implant Engineering and many othersThis list grows with every project. Signed and sealed letters are collected below on this page.
Our partners
Need an ISO 13485 certificate?
Tell us about your manufacturing and devices. We will assess the work needed before the audit.
Discuss your QMS ↗- 15+engineers and specialists
- 10+ yearsof experience among our leading specialists
- 450+projects of any complexity
Have questions or need a consultation?
What would you like help with?
- We will look into your task and suggest where to start
- After the review we send a plan: stages, timeline and cost
- You talk directly to the specialist who runs the project