Compliance & Standards
Quality at DIGITALGATE AMG means certifications we can prove, regulatory obligations documented in our deliverables, and engineering practices applied on every project — including the high-reliability work our customers in medical-device, aerospace and other regulated industries depend on.
Active Certifications
ISO 9001:2015 — Quality Management System
- Certificate number: C1764
- Issuing body: ISOTRANS (Romania)
- Accreditation: IMAB — International Management Accreditation Board
- Issued: 17 April 2026
- Valid through: 16 April 2027 (annual surveillance)
- Scope: Manufacturing of electronic subassemblies (modules) and electronic components
Verify this certificate at https://isotrans.ro/certificate.
EU Regulatory Compliance
For products placed on the EU market, our designs and assemblies meet the following regulatory frameworks. Per-project documentation is provided with the technical file.
- CE marking — conformity with applicable EU directives (EMC, Low Voltage, RED and others), declared via the technical file prepared for each product.
- RoHS (Directive 2011/65/EU) — restriction of hazardous substances in electronic assemblies, including lead-free soldering processes.
- REACH (Regulation EC 1907/2006) — declaration of substances of very high concern (SVHC) in components and finished assemblies.
- WEEE (Directive 2012/19/EU) — design considerations and documentation supporting end-of-life recovery of electrical and electronic equipment.
Quality Practices
IPC-A-610 Class 3 trained assembly operators
Our assembly personnel are trained to IPC-A-610 Class 3 workmanship criteria — the acceptability standard applicable to high-reliability electronic products. Training is internal and ongoing; we do not currently hold a separate IPC certification at facility level.
IPC J-STD-001 Class 3 soldering criteria
Hand-soldering and rework on high-reliability assignments are performed to IPC J-STD-001 Class 3 acceptance criteria — the standard that pairs with IPC-A-610 Class 3 for the process side of an assembly. As with IPC-A-610, this is applied as a workmanship standard on the line; we do not currently hold a facility-level J-STD-001 certification.
ESD and contamination control
Assembly is performed in an ESD-protected area aligned with ANSI/ESD S20.20 practice — controlled flooring, wrist-strap continuity monitoring, ionisation at sensitive workstations, and station-level test logs. ESD compliance evidence and contamination-control records are available on request and are intended to be compatible with incoming-inspection requirements typical of medical and aerospace customers.
Traceability — components, lots, operators and serial numbers
Every assembly is tied to a build record that captures component manufacturer part numbers and lot/date codes for critical parts, the operators who built and tested the unit, the test results retained, and a serialised unit identifier carried through to ship. For medical-device customers this record maps onto a Device History Record entry; for aerospace customers it supports First Article Inspection (AS9102) when the FAI is conducted inside your QA flow.
Counterfeit-component avoidance
Bills of materials are sourced from franchised distributors as a matter of policy. When a customer instructs us to source from the open market — typically for end-of-life parts — we flag the deviation, document the distributor and test the parts to the level the customer specifies. The approach is aligned with the intent of AS5553 / AS6081, applied as a procedure rather than claimed as a certification.
Design files, IP and revision control
Customer schematics, layouts, firmware and BSP source code remain the customer’s intellectual property. Every engagement begins with a mutual non-disclosure agreement, and access is restricted on a need-to-know basis within our engineering team. We operate against a documented revision-control workflow — Git for software and firmware, ECN-controlled releases for hardware — that is auditable on request and is intended to slot into a customer’s design-control or DHF process without rework.
GDPR-compliant data handling
Customer design files, personal data and project correspondence are processed under our GDPR procedures. A data processing agreement (DPA) is available on request.
On Our Roadmap
The following items are planned, not yet in place. We list them here so prospective customers can assess timing against their own programme needs.
- Migration to a RENAR-accredited certification body. At our next ISO 9001 renewal in 2027, we plan to move to a certification body accredited by RENAR — and through it the IAF Multilateral Recognition Arrangement. Candidates include TÜV Austria Romania, Bureau Veritas Romania, DEKRA or a comparable major CB.
- One regulated-vertical certification, 2027–2028. We intend to pursue a sector-specific QMS certification driven by customer pipeline — most likely ISO 13485 should demand from medical-device clients materialise. We will not announce a target standard until the certification is under audit.
Capabilities for Medical and Aerospace Programmes
DIGITALGATE AMG delivers the embedded software, hardware design, FPGA development and assembly work that medical-device and aerospace programmes depend on. Our engineering and assembly personnel are trained against the standards these industries require, and the documentation we produce is built to integrate directly into your design-control, technical-file and certification processes.
Medical devices
We deliver embedded software development, hardware design and PCB layout, firmware integration and test-system development for medical-device programmes. Our work is documented for compatibility with EU MDR 2017/745 and FDA 21 CFR Part 820 design-control requirements; risk-file inputs follow ISO 14971; usability-engineering deliverables are produced to IEC 62366. Assembly personnel are trained to IPC-A-610 Class 3 and IPC J-STD-001 Class 3 — the workmanship classes applicable to high-reliability medical-device builds.
Aerospace and defence
We deliver hardware and FPGA design, embedded software development, firmware and integration support for aerospace and defence customers. Our engineers work to DO-254 (hardware) and DO-178C (software) design-assurance objectives; environmental qualification is supported to DO-160 and MIL-STD-810. Counterfeit-component avoidance procedures align with AS5553 / AS6081. Assembly is performed by personnel trained to IPC-A-610 Class 3 and IPC J-STD-001 Class 3 — the workmanship classes used across aerospace electronics.
Need to verify a specific standard for your project?
Contact our engineering team — we’ll walk you through how our capabilities and trained personnel can support your project.