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NL-004

2017

FDA MEDICAL DEVICE USER FEE 2018
FDA fee 2018
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Facts

Date of publication:
01.09.2017

Topic:
FDA Medical Device User Fee 2018

FDA Medical Device User Fee 2018

Starting with FDAs Fiscal Year (FY) 2017, beginning October 1, 2017, the annual establishment registration and payment of the annual fee is due for every medical device establishment registered with the FDA.

The registration fee for the FY2018 is US$ 4,624.- and must be paid at the latest by December 31, 2017, otherwise, the registration status is suspended until the appropriate fee has been paid.

Of course we support you with the annual registration process - please contact us in case of questions, we are looking forward to provide our service to you.

 

 

 

NL-002

2017

GMP & Regulatory affairs Conference 2017
We want to invite you to our GMP & Regulatory Affairs Conference in 2017.
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GMP & Regulatory Affairs Conference 2017

Facts

Date of publication:
March 29, 2017

Topic:
GMP & Regulatory Affairs Conference 2017

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Unfortunately, our GMP & Regulatory Affairs Conference is only available in German.

 

 

NL-001

2017

MEDAGENT is awarded as "Great Place to Work"
MEDAGENT belongs to one of the best employer in Baden-Württemberg
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Details

Facts

Date of publication:
23.02.2017

Topic:
MEDAGENT is awarded as "Great Place to Work"

MEDAGENT is awarded as "Great Place to Work"

Mühlheim, February 23, 2017. MEDAGENT GmbH & Co. KG is awarded as one of the best employer in Baden-Württemberg in 2017 for its good workplace culture in the Great Place to Work® state competition. The award stands for special performance with a trustful collaboration within the company.

The companies, which are characterized by trustful and attractive workplace culture from the employee's point of view, receive the Great Place to Work® logo. The results are based upon an anonymous employee survey abouth themes like trust in management, identification with the company, professional development opportunities, reimbursement, workplace health promotion and work-life-balance. Furthermore, the quality of measures and offers of personnel work within the company has been valuated.

"We are proud of our company and our staff. We can only achieve our targets with team spirit, high identification with the company and enthusiasm for the common collaboration. Our staff rises above limits for our clients and their needs as well as for our mission - looking for new ways, finding solutions", said Nicole and Franz Menean, managers of MEDAGENT GmbH & Co. KG.

Companies with all sizes and sectors took part in study of quality and attractiveness of workplace culture and surrendered a voluntary survey by the independent Great Place to Work® institute. Partners of the competition are "Bundesverband mittelständische Wirtschaft" (BVMW), Demographie Netzwerk e.V. (ddn) as well as "Wirtschaftswoche" and "Handelsblatt" as media partners.

"The award stands for a good and authentic organizational culture that is affected by trust, appreciation and team spirit", said Andreas Schubert, manager of the German Great Place to Work® institute. "Attractive working conditions and a wholesome culture of collaboration are the central key for employee loyalty and company success.

100 percent of MEDAGENT staff, that took part in the survey, says that the feeling of "family" respectively good team spirit is lived within the company and that the own work is an important contribution for the company.

Further information can be found:

Great Place to Work®: http://www.greatplacetowork.de/beste-arbeitgeber-in-baden-wuerttemberg-2017


 

 

 

 

 

NL-006

2015

Clinic-Research-Industry
1st Neuruppiner innovation forum for the collaboration in health management.
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Details

Facts

Date of publication:
01.12.2015

Topic:
1st Neuruppiner innovation forum for the collaboration in health management

Clinic-Research-Industry - 1st Neuruppiner innovation forum


Unfortunately, the conference is only available in german.

 

 

NL-005

2015

REVISION ISO 13485
Extensive revision of ISO 13485.
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Details

Facts

Date of publication:
24.09.2015

Topic:
Extensive revision of ISO 13485

Revision ISO 13485

ISO 13485 is reworked considerably at the moment. Additional requirements can be found in labeling obligations and in technical documentations.

According to currently aivailable draft, the revision contains following contents:

  • Chapter quality management includes extensions in the sector of risk based decisions for development of every single process.
  • The target of Management Review is an in time recognition and in time act for changed regulatory requirements.
  • An important point lies in the sector of human resources and refers to a documented method for registering a training need and proof of effectiveness of training arrangements.
  • Requirements to design and development were expanded and concern especially the Design History File. New subscription of chapter Design Transfer, Design Reviews, requirements to software etc. belong to the expanded requirements, too.
  • Additional requirements for qualification and surveillance of supplier were defined.
  • Communication with agencies, handling with claims and reworking measures were prepared as new chapters.

The discharge of the revision ISO 13485 was shifted to the 1st quarter in 2016 according to unconfirmed information.

NL-004

2015

2nd cleaning and passivation conference of the Bernd Olschner GmbH
Repetition of 2nd cleaning and passivation conference of the Bernd Olschner GmbH.
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Details

Facts

Date of publication:
08.09.2015

Topic:
Repetition of 2nd cleaning and passivation conference of the Bernd Olschner GmbH

2nd cleaning and passivation conference

There will be a repetition of the 2nd cleaning and passivation conference on the 29th of September, due to the high demand of this event in March 2015.

More information as well as the registration form you can find here.

NL-003

2015

FDA published rule for eMDR
FDA published final rule for submitting electronic Medical Device Reportings.
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Details

Facts

Date of publication:
06.08.2015

Topic:
FDA published final rule for submitting electronic Medical Device Reportings

Electronic Medical Device Reportings

On February 13, 2014, the FDA published a final rule on electronic Medical Device Reportings (eMDR) that requires manufacturers and importers to submit MDRs to the FDA in an electronic format. It is an important step toward improving the Agency's systems for collecting and analyzing postmarket MDRs. Manufacturers and importers have to begin submitting all MDR reports electronically by August 13, 2015.

The FDA also released a guidance to answer questions related to FDA's final rule to submit mandatory MDRs electronically. You can find the guidance here:
http://www.fda.gov/RegulatoryInformation/Guidances/ucm175805.htm

Electronic submission of MDRs will have several benefits like reducing industry's and Agency's time and costs, reducing the transcription errors and enhancing the Agency's ability to rapidly communicate information.

The eMDRs use the FDA Electronic Submissions Gateway (ESG), an agency-wide entry point for all electronic submissions to receive electronic MDRs.

To submit MDRs electronically, you will need to set up a WebTrader Account. Detailed instructions can be found at:
http://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/ucm114831.htm

The FDA has two options for manufacturers and importers for submitting MDRs electronically , the eSubmitter and the HL7 ICSR method.

If you have further questions, please do not hesitate to contact us at any time.

 

 

 

 

 

NL-002

2015

MEDAGENT Regulatory affairs Conference 2015
We want to invite you to our MEDAGENT Regulatory Affairs Conference in 2015.
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Details

Regulatory Affairs Meeting 2015

Facts

Date:
June 24, 2015

Topic:
MEDAGENT Regulatory Affairs Conference 2015

Save the date

We want to call attention to our MEDAGENT Regulatory Affairs Conference in
June 24, 2015
.

Planned topics are:

  • UDI - Unique Device Identifier
  • Status quo of the planned EU-prescription for medical devices
  • Feedback from FDA-inspections
  • New revision of ISO 13485
  • ...

You can find registration and further information here.

 

 

NL-001

2015

FDA REQUIRES Udi FOR IMPLANTS...
Starting in September 2015 FDA requires UDI i.a. for implants.
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Details

Unique Device Identification (UDI)

Facts

Date of publication:
25.03.2015

Topic:
FDA requires UDI in September 24, 2015

What is UDI?

UDI is a program for the uniform identification of medical devices. It is important to transfer the data of the products to the FDA, thereby they are accessible as well as they can be stored and archived in the central database “Global Unique Device Identification Database“ (GUDID). The “GUDID” is a public accessible reference catalog. The products and packages are marked by a code, which contains the important data of products and producer information, e.g. charge number and expiry date. In addition the UDI will be complemented through logistic codes in order to register moving and transportation as well as handling of processes like sterilization. Therefore manual entries drop out, processes can be automated and documented faultless. The codes serve as internal registration for producer. Recipients use the code for receipt of goods, intermediate storage and booking the consumption. A UDI identification on the product isn’t prescribed for all medical devices. It has to be indicated on the product, if this is intended for repeated utilization and no exception is applied, named in 21CFR §801.45(d). If a producer wants to export their products to the USA furthermore, they have to comply with the guideline and that between one and five years according to the risk class of the products.

When does the UDI identification start to apply?

In September 2013 it was decided, that the requirements should apply in September 2014 for all products with risk class III. Despite of the advantages the introduction isn’t realizable by implication. So the appointed date for the utilization of the UDI guidelines for medical devices had to be shifted. It is distinguished between the identification at the package and the identification on the product. That means that producer of Class II and Class I medical devices and implants have to provide the UDI packaging about a period till 2018 (FDA demands UDI i.a. for implants at September 24, 2015, see http://1.usa.gov/15XjYmG). Step by step the UDI identification on the product is going forward. The period lies between 2016 (Class III) till 2020 (Class I).
It is important that after the respective appointed date only products with the UDI packaging code will be allowed on the market.


Two parts of UDI

  • Device Identifier (DI) with static data, e.g. ISO-based code for identifying the article.
  • Production Identifier (PI) with dynamic data, e.g. charge number, serial number, expiry date.

Further information:
http://www.medizin-und-technik.de/recht/-/article/33568401/40359954/Erleichterter-Einstieg/art_co_INSTANCE_0000/maximized/

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MEDAGENT GmbH

Griesweg 47
D-78570 Mühlheim
Germany
Tel.: +49.7463.9954.0
Fax: +49.7463.9954.10
E-mail: info(at)medagent.de

MEDAGENT Inc.

Pease International Tradeport
112 Corporate Drive, Unit 1
Portsmouth, NH 03801, USA
Tel.: +1.603.570.2039
Fax: +1.603.570.2055
E-mail: mail(at)medagent-usa.com

MEDAGENT do brazil ltda.

Rua Jurubatuba, 1350 - Sala 1520 - Centro
São Bernardo do Campo - SP
CEP 09725-210, BRAZIL
E-Mail: info(at)medagent-brazil.com