Strategy & Implementation

Regulatory Services

Our Approach

Kalms Regulatory team assesses your product with its profound market knowledge and strong analytical capabilities.
We understand the value of your product and will reflect that in a streamlined regulatory strategy.

Our service will assist you in utilizing compliance requirements as a business value and transform them into success.
From initial design and development to management of medical devices and in vitro diagnostics, our services
help clients to efficiently establish, implement and maintain all relevant framework processes and documents.

We believe that early assessment, preparation and constant product and process improvements are key to face
the new MDR and IVDR requirements and challenges in Europe and will make your product,
the healthcare market and in conclusion patients’ lives safer and better.

Gap Analysis

In a gap analysis, we start with a description of the MDR/IVDR regulatory framework. This will reflect the requirements your product and company need to reach MDR/IVDR compliance accordingly, either from scratch or for MDD/MDR and IVDD/IVDR transition, respectively.

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Regulatory Compliance Strategy

Timely analysis of the impending, sophisticated regulatory requirements is key to develop a basic strategy to further develop the company`s medical device and in vitro diagnostic business in the European market and to ensure gapless regulatory compliance.

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Technical Documentation Compilation & Update

The Technical Documentation (TD) is a basic requirement no matter which risk class your medical device belongs to. It demonstrates compliance with the applicable and relevant legislation, such as the medical device regulation EU/2017/745 (MDR) and the in-vitro diagnostic regulation EU 2017/746 (IVDR).

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Quality Management System (QMS) Setup

Adequate quality management is crucial for the manufacture of medical devices in accordance with the statutory regulations. Furthermore, customers demand proof of the quality of a medical product – a QMS creates confidence.

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Post-Market Surveillance (PMS)

With the introduction of the MDR/IVDR, the requirements for market observation are increased by obligations in reporting and interlocking vigilance and PMS.

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Unique Device Identification (UDI) System

With MDR / IVDR implementation, the Unique Device Identification (UDI) System became mandatory for MD and IVD manufacturers for identification and registration of medical devices.

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Notified Body Selection & Coordination

MDR / IVDR implications not only affect manufacturers but also Notified Bodies. Early contact with MDR / IVDR designated Notified Bodies is key to compete now and in the future in the Medical Device market.

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Person Responsible for Regulatory Compliance (PRRC)

The person responsible for regulatory compliance (PRRC) is a new position defined in Article 15 of the MDR/IVDR Regulations. Legal Manufacturers and Authorized Representatives must each have their own PRRC. Legal obligations are associated with this role and a certain skill set must be fulfilled.

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Your business is our business. So weather you need first ideas
or a second opinion: We’re here to listen – and ready to answer.

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