Consulting for management systems, MDR, Machinery Regulation and AI Act for industry and medical technology

beluqua GmbH

Annaberg-BuchholzNew on Amplifa

GmbHLegal form

HRB 24735, Chemnitz Local CourtCommercial register

Annaberg-BuchholzCompany headquarters

About beluqua

beluqua GmbH is a consulting company based in Annaberg-Buchholz in the Erzgebirge. The company supports businesses in establishing and certifying management systems (OMSYS) in accordance with DIN EN ISO 9001, 13485, 14001, 50001, 45001 and 27001 as well as IATF 16949 and VDA 6.3. Another focus is consulting on the Medical Device Regulation (MDR) for manufacturers of medical devices. beluqua also accompanies companies in implementing the new Machinery Regulation (EU) 2023/1230, which becomes mandatory on 14 January 2027 – from gap analysis and risk assessment and documentation through to CE marking and conformity assessment. In addition, the company offers consulting on the AI Act for the use of artificial intelligence in products. Services also include training, workshops and technical support as well as the software products OMSYS 5 LIFE and OMSYS 5 Pro. Target industries are medical technology, automotive and mechanical engineering.

Site: Annaberg-Buchholz
Processes: Management systems consulting (OMSYS, DIN EN ISO 9001/13485/14001/50001/45001/27001, IATF, MDR consulting (Medical Device Regulation), Consulting on the Machinery Regulation (EU) 2023/1230 incl. gap analysis, risk assessment,, Consulting on the AI Act / Artificial Intelligence, Management systems consulting (OMSYS), Support with the Medical Device Regulation (MDR), Consulting on Artificial Intelligence / AI Act, Consulting on the Machinery Regulation (EU) 2023/1230
Materials: OMSYS management systems, Medical Device Regulation, Machinery Regulation, Artificial Intelligence
Industries: Medical technology, Automotive, Mechanical engineering

01
Assessment and gap analysis
02
Risk assessment and documentation
03
Implementation and rollout
04
Training and workshops
05
CE marking and conformity assessment
06
Technical support and ongoing support

Service Areas

OMSYS

OMSYS management systems

Consulting and software for management systems according to DIN EN ISO 9001/13485/14001/50001/45001/27001 as well as IATF 16949/VDA 6.3.

MDR

Medical Device Regulation

Support for medical device manufacturers in meeting MDR requirements.

EU 2023/1230

Machinery Regulation

Guidance on implementing the new Machinery Regulation including CE marking and conformity assessment.

AI Act

Artificial Intelligence

Consulting on the AI Act and on AI requirements in machinery and products.

Location

Annaberg-Buchholz

Company headquarters

Industries

Medical technologyAutomotiveMechanical engineering

Processes & technical limits

Processes	Tolerance	Max. part	Weight	Lot size	Materials
Management systems consulting (OMSYS, DIN EN ISO 9001/13485/14001/50001/45001/27001, IATFEngineering	–	–	–	–	–
MDR consulting (Medical Device Regulation)Engineering	–	–	–	–	–
Consulting on the Machinery Regulation (EU) 2023/1230 incl. gap analysis, risk assessment,Engineering	–	–	–	–	–
Consulting on the AI Act / Artificial IntelligenceEngineering	–	–	–	–	–

Additional services

Management systems consulting (OMSYS)Support with the Medical Device Regulation (MDR)Consulting on Artificial Intelligence / AI ActConsulting on the Machinery Regulation (EU) 2023/1230Gap analysis and assessmentRisk assessment and documentationTraining and workshopsCE marking and conformity assessmentTechnical supportSoftware: OMSYS 5 LIFE and OMSYS 5 Pro