Manufacturer's support from A-Z

WE ACCOMPANY YOU CLINICALLY FROM IDEA TO APPROVAL TO PMS

The entire development period of a medical device, which lasts on average more than 4 years, includes clinical aspects from the beginning and can therefore be clinically monitored. In addition, support may come in the clinical PMS.

Statutory clinical accompaniment

Below you will find important steps and documents of the manufacturer that depend directly or indirectly on a legally prescribed clinical evaluation:

Clinical development plan

Clinical development plan

For the clinical evaluation of medical devices, it is new, according to the EU MDR, that manufacturers may have a clinical development plan including ...

Clinical evaluation procedure

Clinical evaluation procedure

The new EU regulations have the requirements for the burden of proof of safety and efficacy by means of clinical evaluation and if necessary. ...

Revaluation of old certificates

Revaluation of old certificates

Clinical reassessment of approved medical devices with existing certificates between 2020 and 2024 The new EU MDR will apply from 26 May 2020. Products already approved for the market must be submitted no later than 5 ...

Clinical examination

Clinical examination

If sufficient clinical evidence is not available to demonstrate the required clinical safety and performance of a product, clinical trials must be carried out ...

Software review

Software review

Special features of the clinical evaluation of stand-alone software. According to Classification Rule 11 EU-MDR, individual software (eg identifiable by the restriction to (possibly graphic GUI) is used).

Elimination of clinical evaluation ?

Elimination of clinical evaluation ?

A waiver of clinical data in a clinical evaluation is only intended for absolutely non-critical products (MDR, Annex X, section 1.1d). The exception is with proof of the ...

Gap analysis

Gap analysis

Existing gaps in clinical documentation and assessment must be uncovered and closed. This may require clinical trials or post-marketing surveillance. ...

Clinical documentation

Clinical documentation

Documentation for Clinical Conformity Assessment In addition to the medical quality of the clinical assessment, its documentation and traceability must also be documented in the context of complex reports and ...

Clinical PMS

Clinical PMS

Continuous post-marketing clinical monitoring. After the market launch of the medical device, according to the new MDR (Annex XI ...

Recertification

Recertification

The CE marking is limited in time After the initial certification, the notified body carries out annual repeat audits ....

Tools

Tools

Our seven implementation modules as intelligent tools for tailor-made solutions Our proprietary implementation modules cover all the typical questions of manufacturers from the first ...

Optional clinical support

Other important operations and documents of the manufacturer that may be affected by the clinical sphere:

Manufacturer's support from A-Z

Manufacturer's support from A-Z

The entire development period of a medical device, which lasts on average more than 4 years, includes ...

Counseling the product idea

Counseling the product idea

The question of redeveloping a product based on an idea touches on equally profound strategic, operational and economic ...

Patenting

Patenting

Intellectual properties often have to be secured by means of patents and can be used at the interface of technology and medicine medical writing ...

Classification

Classification

Impact of Classification on Manufacturer's Expenditure Classification has a significant impact on the necessity and extent of any clinically required disease.

Preclinical tests

Preclinical tests

The planning and execution of a substantial part of the preclinical tests of the future medical device will naturally depend on the late ...

Scrutiny method

Scrutiny method

The new Scrutiny procedure focuses on the regulatory review of the submitted clinical evaluation by the European Commission. For this the notified...

Conformity procedures

Conformity procedures

The market approval takes place by means of conformity assessment procedures with the following CE marking. After the new EU MDR, the Clinical application...

Risk management

Risk management

The clinical evaluation has a special impact on risk management The results of the clinical evaluation have a significant impact on risk management. Only the clinical evaluation can ...

G-BA/NUB procedure

G-BA/NUB procedure

In the outpatient area, a reservation of authorization applies to the distribution of medical devices at the expense of the statutory health insurance. You may only after a positive decision of the ...

Management consulting

Management consulting

Specialists with completed additional training in Business Administration (MBA) or international professional experience in global consulting Firms offer at the interface of medicine and business management ...

With these clinical modules we accompany you ..

1.0 Medical Counselling & Scientific Advice

1.0 Medical Counselling & Scientific Advice

We can accompany you from the product idea to the approval to clinical PMS. The entire development period of a medical device can be described in many development phases by Prof. Zenner and...

2.0 Clinical Evaluation.

2.0 Clinical Evaluation.

According to the new EU MDR, proof of clinical effectiveness of a medical device and patient protection is usually provided by a specialist clinical evaluation...

3.0 Clinical Trial.

3.0 Clinical Trial.

If sufficient clinical evidence is not available to demonstrate the required clinical safety and performance of a product, clinical trials must be performed. Novel products, implantable medical devices, and Class III products must be on the .

4.0 Gap Analysis

4.0 Gap Analysis

The Clinical Gap Analysis of the Clinical Assessment Center Prof. Zenner covers existing gaps in clinical documentation ...

5.0 Clinical Support.

5.0 Clinical Support.

The entire development period of a medical device can be clinically supported by Prof. Zenner and his partners in many development phases. In addition, medical support for the clinical PMS ...

6.0 Clinical Writing

6.0 Clinical Writing

The clinical evaluator Prof. Zenner and Partners can assist the company in the conformity assessment procedure by means of process-compliant documents and clinical writing.

7.0 Medical Strategy & Business Consulting

7.0 Medical Strategy & Business Consulting

Specialists with completed additional training in Business Administration (MBA) or international professional experience in global consulting Firms offer at the interface of medicine and business management ...

Das unterscheidet uns:

Wir können Sie als Hersteller von der Idee über die Zulassung bis zur PMS klinisch begleiten.

Der gesamte Entwicklungszeitraum eines Medizinproduktes kann in vielen Entwicklungphasen von Prof. Zenner und seinen Partnern klinisch begleitet werden. Hinzu kann die medizinische Unterstützung bei der klinischen PMS kommen.

Unser Fokus:

Die klinische Bewertung von Medizinprodukten und ihre Begleitung bis zu Konformitätsbewertung und klinischer PMS.

Zentrale

0700-02 98 80 13 (Ortstarif)
office@hpzenner.de

Büro München

Oettingenstr. 8a
8xxxx München
Tel. 089-xxxxxxx
office@hpzenner.de

Büro Tübingen/Stuttgart

Bismarckstr. 66
72072 Tübingen
07071-49645
office@hpzenner.de