Quality & Certifications for Electrosurgical Instruments

ISO 13485 Certified Medical Device Manufacturing

Electro Bismed operates under a certified ISO 13485 Quality Management System, specifically developed for medical device manufacturing.

Our ISO 13485 compliance ensures:

• Controlled and documented manufacturing processes

• Full product traceability from raw material to finished device

• Risk management throughout product lifecycle

• Consistent quality for OEM and private label production

• Continuous monitoring and improvement of product safety

This system enables us to deliver hospital-grade electrosurgical instruments that meet international expectations for reliability and performance.

CE Certified Electrosurgical Instruments

Our electrosurgical instruments are CE marked, allowing them to be legally marketed and used within the European Economic Area (EEA).

CE certification confirms that our products comply with essential requirements related to:

• Patient and user safety

• Electrical and mechanical performance

• Biocompatibility of materials

• Manufacturing quality and documentation

This certification provides assurance to distributors and healthcare providers that our instruments meet European regulatory standards.

Compliance with CE Directive 93/42/EEC

Electro Bismed’s electrosurgical instruments are certified in accordance with CE Directive 93/42/EEC for Medical Devices.

This directive ensures that:

• Devices undergo conformity assessment procedures

• Products meet essential health and safety requirements

• Technical documentation is reviewed and maintained

• Manufacturing processes are regularly evaluated

Compliance with this directive enables smooth market entry and regulatory acceptance across Europe.

Certified by Notified Body 1639 (SGS Belgium NV)

Our CE certification is issued under Notified Body 1639 – SGS Belgium NV, an internationally recognized and authorized European notified body for medical devices.

Certification by SGS Belgium NV confirms:

• Independent verification of compliance

• Assessment of quality systems and technical files

• Ongoing conformity surveillance

This adds an extra layer of confidence for our OEM partners and international buyers.

OEM & Private Label Compliance Support

In addition to certified manufacturing, Electro Bismed provides regulatory-ready OEM and private label solutions for global brands.

We support our partners with:

• Certified manufacturing under their brand name

• Documentation aligned with ISO 13485 and CE requirements

• Export-ready products for regulated markets

• Consistent quality across repeat production batches

This allows distributors and brand owners to focus on sales and market growth while relying on a compliant and experienced manufacturing partner.

Commitment to Safety, Performance & Continuous Improvement

Our commitment to quality goes beyond certifications. Each product undergoes defined quality checks to ensure:

• Precision manufacturing

• Functional reliability in surgical environments

• Compliance with customer and regulatory requirements

Through continuous improvement, training, and process control, we ensure that every electrosurgical instrument leaving our facility meets the expectations of modern healthcare systems.

Partner with Electro Bismed

Certified Manufacturer of Electrosurgical Instruments

Whether you are a distributor, hospital supplier, or brand owner seeking OEM or private label solutions, Electro Bismed offers certified manufacturing you can trust.

Contact us today to learn how our quality systems and certifications support your business growth in regulated markets.