Services

We offer consultations relating to the testing and approval of medical devices. Moreover, we support you with the creation of your CE documentation. Additionally, we register your products in national reimbursement systems or assist you in setting up a quality management system. Thanks to many years of experience and competent specialists, BEO BERLIN is able to accelerate the entry of your product into the health market. Every year we support over 250 product registrations in the medical technical aids register. Seminars on nursing science topics, medical device law and medical technical aids register (HMV) round off the service portfolio.

consulting

We can efficiently support you with the conformity assessment procedure according to MDD/MDR, the application for an HMV code and implementation of a QM system.

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compiling

We can handle your regulatory requirements for you, including by preparing individual documents, evalluations, complete documentation or applications.

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coordinating

We can assist you with required testing and case reports to ensure your verification procedure is fully recognised, from product testing to successful test report.

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Standard in Focus: DIN EN ISO 15223-1:2020-04 – Draft

This month, DIN EN ISO 15223-1:2020-04: Medical devices (draft) was published

Does a Clinical Evaluation Help to Prove the Medical Benefit in the Context of an HMV Application?

A case report on the medical benefit with one’s own product can possibly fill a gap in the clinical evaluation despite not having too much evidence.

New Standards and Standard Projects in June 2021

DIN CEN ISO/TS 5499 (Project)
DIN EN 00205320 (Project)
ISO/AWI 8549-2 (Project)
DIN EN ISO 10993-18/A1 (Project)
DIN EN 15194/A1 (Project)
DIN EN ISO 81060-3 (Draft)
DIN EN ISO 80601-2-70
DIN 58950-2
DIN 58950-3
DIN EN ISO 80601-2-67
DIN EN ISO 80601-2-69

EUDAMED – Companies are transparently registered. How about you?

In EUDAMED everyone can gain insight into your rule-compliant registration. Unlike in the past, companies are transparently registered.

Who Needs A Person Responsible for Regulatory Compliance?

Who needs a Person Responsible for Regulatory Compliance? From a German perspective, the PRRC replaces the safety officer.

Hilfsmittelverzeichnis: Update of Product Groups 23, Orthoses and 52, Nursing Aids

Two Hilfsmittelverzeichnis product groups have recently been updated; product group 23 orthoses and product group 52 nursing aids for more independent living / mobility. This translates into changes regarding structure and / or requirements.

Clinical Evaluation MEDDEV 2.7.1 in 5 Steps

A clinical evaluation according to MEDDEV 2.7.1 is carried out in 5 steps. Preparation or step 0 is the creation of the clinical evaluation plan based on the essential safety and performance requirements to be addressed.

Gebrauchsanweisung für Himi-NummerBEO BERLIN

Do My Instructions For Use Fulfil CE and HMV Requirements?

What is important when it comes to instructions for use for a medical device? The content of an instruction manual for a medical device can be quite tricky. The requirements…

Declaration of Conformity and Sale of Stock as of May 25th

Declaration of Conformity as of May 25th, 2021: With the start of the sole validity of the MDR, your products must be placed on the market in compliance with its requirements.

EUMMAN Network Extends Reach

In April 2021 our independent European Medical Market Access Network (EUMANN) has expanded to include Azierta in Spain.