Challenge MDR 2020 - We pave the way for your Clinical Evaluation Report

Clinical Research Organisation | European Clinical Evaluation Report Services | By certified German Medical Doctors | According to MEDDEV 2.7 / 1 Rev. 4 and MDR | Regulatory partner of the medical device industry | We are based in Germany

MDR COMPLIANT CLINICAL EVALUATION REPORT SERVICES (CERS) BY CERTIFIED MEDICAL DOCTORS

CERS & MORE

Tailored for you by experienced German Medical Doctors from most medical specialities.

Our focus is your time to the market.

SCHEDULE OF SERVICES

INTELLIGENT CLINICAL TOOLS FOR MDR COMPLIANCE

Our goal is your regulatory compliance

We are Medical Doctors - reach your MDR compliance with our clinical experience

Notified bodies are increasingly expecting Medical Doctors as clinical evaluators

This is due to the stricter clinical requirements of the new EU Medical Device Regulation (MDR) of 2017. The current clinical procedures for CE certification according to the German MPG and the European guidelines MDD / AIMDD / IVD expire in 2020. Old certificates end no later than 2024: more...

OUR SOLUTION

HPZenner Clinical Evaluation Reports are formulated and signed by board certified German medical specialists.

Our MDs can also assist you with a constructive review of existing or pre-formulated documents.

Our service areas for manufacturers

Clinical Support in 12 other areas

Twelve further clinical fields of the manufacturer's activity - for all twelve we are available with Clinical & Scientific Advice and Support from the product idea through the approval to distribution.

The entire development period of a medical device, marketing and sales are subject to further clinical questions and action areas and can be clinically supported by us beyond the legal requirements.

Product idea

Patenting

Development decision

Classification

Preclinical testing

Waiver of a clinical evaluation

Medical monitoring of the conformity procedure

Medical comparison with risk management

Scrutiny method

Distribution channels / reimbursement

Business Management

Strategy

more...

Clinical Methodology in 7 proprietary modules

Our seven proprietary implementation modules as intelligent tools for customized solutions

Our proprietary implementation modules cover all the typical questions of manufacturers - from the initial consultation on idea, patenting and development start to gap analysis, clinical advice & support, clinical evaluation including clinical examination evaluation, clinical monitoring and clinical writing with approval-compliant documentation to personnel development as also strategy, process and quality optimization.

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 ...

Clinical Evaluation in all 8 fields of action

Eight statutory clinical fields of action for the manufacturer - as Clinical Evaluator we take over or support the statutory clinical evaluation and documentation of the manufacturer as well as the clinical PMS.

Clinical development plan

Clinical evaluation

Clinical examination

Clinical PMS

Clinical documentation

Compliance with medical regulations and standards

Medical evaluation for recertification

Clinical reassessment of medical devices approved according to old regulations

more...

Fields of action for manufacturers from 2017-2024

The challenges for you as a manufacturer of medical devices

With regard to the clinical evaluation, the further challenges facing medical device manufacturers are mainly due to the differences between EU Directive 93/42 and EU Regulation 2017/745 in six main areas:

6 major challenges for manufacturers
1. Stricter clinical functional requirements

1. Stricter clinical functional requirements

Under the new EU MDR, manufacturers must be able to prove, in principle, the clinical efficacy and effect size, the burden and risks, and the reasonableness of the benefit / risk balance by a clinical evaluation of their products. A clinical trial on patients ...

2. New classification increases the effort

2. New classification increases the effort

In the course of MDR, the previous assignment of some medical devices to a class in comparison to the expiring in 2020, previous methods according to MDD, ...

3. Clinical evaluation is much more demanding

3. Clinical evaluation is much more demanding

For an EU MDR-appropriate clinical evaluation, a clinical evaluator is required. More often than before a clinical trial according to EN ISO 14155 is required.

4. Elaborate clinical post market surveillance

4. Elaborate clinical post market surveillance

In accordance with EU MDR Annex XIV Part B, Post Market Surveillance (PMS) is an ongoing process of updating ...

5. More extensive clinical documentation

5. More extensive clinical documentation

The considerably more extensive reporting includes the results of the clinical evaluation, if necessary. including the documents for the clinical trial, as well as additional reports and ...

6. Unknown new Scrutiny method

6. Unknown new Scrutiny method

The new Scrutiny method is used i.a. for toughening the Clinical Assessment of Part of the Class III Implantable Products or Actuarial ...

Further challenges for manufacturers

The entire development of a medical device, marketing and sales can affect more than the legal requirements and other clinical issues and action areas. more...

Typical examples are
- entrepreneurial decisions on product idea, patenting and development start,
-Classification, preclinical testing or omission of a clinical evaluation as well as
- medical monitoring of risk management, conformity procedures or scrutiny procedures.

With additional challenges
- Distribution channels (eg reimbursement by the GKV) as to
- Business Management and
- Strategy of the company come.

Prof. Zenner's memberships

Medical Association Baden-Württemberg, Stuttgart

Bavarian Medical Association, Munich

N.Y. Academy of Sciences, New York

Académie Nationale de Médicine, Paris

National Academy of Sciences Leopoldina, Halle/Berlin

So that the future does not overtake you.

Success for you.

Your success is our focus. We perform the Clinical Evaluation of your medical devices, give clinical advice to conformity assessment, supervise your clinical PMS, and, if required, design your clinical trial.

Tailored for you.

CERS
Clinical evaluation report services acc. EU-MDR / MDD / AIMDD / MPG | Preparation and clinical evaluation of clinical trials according to EN ISO 14155 / MPG / MPKPV | Gap analysis | Clinical Writing / Document Creation acc. EU-MDR / MDD / AIMDD / MPG / MEDDEV 2.7-1 Rev. 4 | Scrutiny / CEAR / MDCG | Clinical Post Market Surveillance according to EU-MDR Annex XIV Part B | Recertification |

CERS & More
Clinical Advice for Product Idea / Patenting / Preclinical Testing / Classification | Process / Structural Engineering | Personnel training | strategy development