Medical devices

We provide comprehensive support for medical device manufacturers: from certification path selection and the design
and execution of clinical investigations, to implementing a QMS and writing documentation for device registration.
We are experienced in assisting digital health start-ups in successful device certification.

regulatory support

As defined in the EU Medical Device Regulation (MDR), a medical device is an “instrument, apparatus, appliance, software, implant, reagent, material, or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more (…) specific medical purposes (…).”

CE is a conformity mark that signifies product compliance with relevant EU regulations and other standards for the type
of product, especially in the areas of safety, quality and clinical performance. PMW helps medical device companies successfully complete the marketing approval process, satisfy the requirements for CE Marking and achieve CE Marking certification.

To obtain a CE mark, manufacturers must:

assess whether the product is a medical device according to the MDR
classify the product
choose the optimal path for the company and product conformity assessment
implement a QMS (optional) and procedures for post-production supervision, incident reporting and document storage
identify the essential requirements for the product and the harmonized standards
implement the requirements of these standards or assess the safety and effectiveness of the declared function
in accordance with the harmonized standards and current knowledge
perform a risk analysis and clinical evaluation and then make the necessary corrections
develop a checklist for meeting the essential requirements
apply for certification by a notified body (optional)
issue a declaration of conformity and report the product to the registry

To address these needs, PMW provides comprehensive services for each stage in the CE marking process:

medical device status confirmation
assistance with product classification based on the level of risk (device class)
identification of applicable essential requirements and other standards
implementation of a QMS, if applicable (usually ISO 13485)
compilation of technical documentation, or review of existing files
risk assessment and management (ISO 14971)
preparation of marketing materials, labelling, and user manual content
preparation of clinical evaluation documentation
coordination of important pre-clinical product testing (e.g., biocompatibility testing, microbiological testing,
transport safety, etc.)
verification of compliance with the general safety and performance requirements (essential requirements)
conformity assessment and declaration of conformity
registration of devices with the competent authority
development of vigilance and post-market surveillance procedures

We also offer comprehensive support on US FDA registration, including consultancy on the pathway to market approval,
QMS implementation, and the writing of device documentation. We offer consultations on any US FDA proceedings.

clinical evaluation reports

According to the MDR, clinical evaluation is defined as “a systematic and planned process to continuously generate, collect, analyse, and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer”.

Clinical evaluation is therefore an ongoing process that occurs throughout the life of a medical device and starts by documenting planned processes in the clinical evaluation plan (CEP). It involves the assessment and analysis of clinical data pertaining
to the medical device to verify its clinical safety and performance. The evaluation is based on the comprehensive analysis
of clinical data relevant to the intended use. The process is documented in a clinical evaluation report (CER). Upon completion, the CER is reviewed to verify if there is sufficient evidence to meet the relevant essential requirements set out in MDR 2017/745.

PMW has the expertise to assist at each step of this process, including the preparation of the CEPs and CERs required for initial CE-marking and subsequent updates. PMW will prepare CEPs and CERs according to EMA and national regulatory authority requirements in a timely and accurate manner.

PMW is experienced in clinical literature reviews and has extensive knowledge of the preparation of fully compliant CERs.

As part of this process, we:

develop a protocol of methodological search and appraisal of published medical evidence including journal articles
and research databases
gather and analyse appropriate scientific literature applicable to your device
compile and draft the CER in compliance with EU requirements
develop procedures to compile CERs and perform clinical literature reviews for future updates to your CE

documentation of CLINICAL INVESTIGATION

According to the MDR, a clinical investigation is ”a systematic investigation involving one or more human subjects,
undertaken to assess the safety or performance of a device”. In addition to clinical investigations, various studies
are needed to fulfil specific requirements and generate new information.

All these medical device studies are essential for:

primary device registration
changes in the intended use (e.g. new indications)
building relationships with the medical community
collecting essential feedback from users
usability tests and other necessary validations

PMW acts as a consultancy firm at all stages of the design and execution of clinical investigations.

We can assist in defining basic study assumptions described in the clinical investigation plan (CIP), such as:

study type, design and methodology
study rationale, objectives and endpoints
study duration
study population:
- size and characteristics
- inclusion and exclusion criteria
biostatistician input – sample size estimation
study procedures

According to the MDR, a clinical investigation is ”a systematic investigation involving one or more human subjects, undertaken
to assess the safety or performance of a device”.

In addition to clinical investigations, various studies are needed to fulfil specific requirements and generate new information.
All these medical device studies are essential for:

primary device registration
changes in the intended use (e.g. new indications)
building relationships with the medical community
collecting essential feedback from users
usability tests and other necessary validations

As the study develops, PMW, in cooperation with CRO partners, provides comprehensive services in support of successful clinical investigations and the collection of reliable scientific evidence. Our key services include:

trial documentation development and management
preparation of an effective study protocol
trial management activities
site selection and management (including investigator recruitment and qualification)
trial registration and approvals
organization of investigator meetings and training of study site teams
study initiation and study closure according to regulatory requirements
medical and clinical monitoring
data management
biostatistics
assistance in the publication of results as scientific papers, congress presentations, and others

PMW follows the guidelines of ISO 14155:2020 Clinical investigation of medical devices for human subjects – Good Clinical Practice, as well as other relevant documents such as the Declaration of Helsinki.