rim software

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MakroCare offers Life cycle maintenance service for medical device manufactures & end users, To maintain quality and compliance of device throughout the life cycle.

Medical device industry faces a world of opportunity. New markets continue to emerge, Patients needs driving novel solutions, technology innovations happening at faster pace, global aging economies, and legislations like Affordable Care Act has introduced new patient populations.for more info visit:https://www.makrocare.com/devices/life-cycle-maintenance

[davidraino]

Software fulfilling the definition of an in vitro diagnostic medical device falls under the In vitro diagnostic medical device regulation (EU) 2017/746 (IVDR). In the past, several of these are self-certified or not covered under IVDD for more info visit: https://www.makrocare.com/blog/ivdr-requirements-for-software

[davidraino]

MakroCare’s Global Medical Device Labeling team provides advisory and implementation services to ensure your compliance maintained at all times, whether it’s local country labels or compliance (EU) 2017/745.

https://www.makrocare.com/devices/labelingWe all know the labeling definition well and that includes any part of written, printed, packaging and Graphics matter that accompanies the product.MakroCare’s Global Labeling team provides advisory and implementation services to ensure your compliance maintained at all times, whether it’s local country labels or international.read more at

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MakroCare’s Publishing & Submission Group (PSG) consists of publishing experts who understand publishing process, content and regulatory requirements to produce high quality regulatory submissions. Our Submission Services are designed to facilitate advanced publishing activities and to extend the capabilities of organizations while utilizing the eCTD format.

Regulatory strategies that integrate electronic document submission and life cycle management into the development process are more efficient and can significantly increase approval chances.

[davidraino]

From IVDR perspective, clinical evidence should support the intended purpose of a device as stated by the manufacturer and that is based on performance evaluation. This is guided by a performance evaluation plan (PEP), as well as a file of clinical evidence should be combined as a performance evaluation report (PER).read more https://www.makrocare.com/devices/clinical/performance-evaluation-report

[davidraino]

Clinical & Medical regulatory Consulting Services

According to the IVDR, clinical evidence must support the intended purpose of the device as stated by the manufacturer and be based on a continuous process of performance evaluation, following a performance evaluation plan. The performance evaluation reports should demonstrate the following elements for more information visit:https://www.makrocare.com/blog/clinical-performance-studies

[davidraino]

MakroCare is expert strategic development and commercialization global partner for pharmaceutical, biotechnology and medical device industries. Our experience, programs and processes bring a new dimension to development strategy, regulatory/risk planning & management, clinical research, medical/scientific support and emerging region expansion.

It has always been a difficult task to be compliant with the changing regulatory norms. When it comes to labeling, the criticality doubles as it becomes necessary to not only be compliant but to even provide the correct instruction for use (IFU). Many companies find it difficult to manage labeling regulations and also remain compliant with it. read more at https://bit.ly/2XtYBpg

[davidraino]

Proactive strategies for Devices to minimize disruption

It is know that Medical devices have long as well as highly regulated life cycles. Most manufacturers handle their devices in market properly with measures like routine and reactive quality, complaint handling and safety. Some additional proactive activities can help manufacturers prepare better for device marketability, competitiveness and reduce disruptions for more info visit:  https://bit.ly/2WEKazu

[davidraino]

Medical Device Regulatory & Clinical Experts for new EU Medical Device Regulation. Our Experts guide your teams for a smooth transition from MDD to MDR & stay compliant. Learn more about our timely solutions today.

Since decades, regulation of the medical device industry in Europe has been rather unchanged. However, recent events have now prompted for vital regulatory & compliance reforms to the medical devices industry. The new Medical Device Regulation adopted by EU, replacing the two existing directives, the Medical Devices Directive (MDD) and the Active Implantable Medical Devices Directive. read more at https://bit.ly/3bAUe0K

[davidraino]

From IVDR perspective, clinical evidence should support the intended purpose of a device as stated by the manufacturer and that is based on performance evaluation. This is guided by a performance evaluation plan (PEP), as well as a file of clinical evidence should be combined as a performance evaluation report (PER)

[davidraino]

Webinar on Euivdr

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Medical Device Life cycle maintenance | MakroCare

MakroCare offers Life cycle maintenance service for medical device manufactures & end users, To maintain quality and compliance of device throughout the life cycle

[davidraino]

Regulatory Data and Info management for Med Device success

With EU MDR changing the plain field of med devices to a whole a new level, other countries are following similar path of increasing demands in product safety, tractability, performance areas

Companies not organised on information management with a system will end up duplicating lot of activities leading to loss of productivity and increase risk of non-compliance

There are 3 categories of Challenges grouped by:

https://www.ddismart.com/blog/regulatory-data-and-info-management-for-med-device-success

Process Challenges:

Training must be required to simplify the complexity of multiple system & user interface. As a result, users work outside of the system using local file shares or email to collaborate.

To check the work status and to create report most of the companies depends on separate reporting tool or manual spreadsheets.

System Challenges:

Medical device regulation is much versatile. Upgrading a system with updated integrations is challenging and expensive as well.

Systems that lie behind corporate firewalls are difficult to outsource to business partners or service providers.

Compliance Challenges:

Users develop manual tracking spreadsheets when planning & tracking capabilities aren’t part of a content management system.

Many times users share information and documents via email that cause inconsistent use of document template and it is much difficult to Re-import.

Importance of a RIM system

Medical device registrations differ from country to country, with the difference in FDA’s 510K (Class I and II devices) and Marketer Approval (Class III devices) processes from the EU’s CE Marking process. The current regulatory environment in which the medical devices and diagnostics companies are competing is complex.

There is a higher demand for regulatory and compliance information required to support submissions 510 (k), PMA, De Novo and HDE.A cloud based RIM  can effectively help management of product registration, commitments and regulatory submissions to medical device and diagnostics companies. This unified, single-source system provides a global user base with real-time information necessary to ensure the quality of the product and the registration.

Following capabilities should be present in an effective regulatory information management system

Identifies device-specific global regulatory requirements

Assembles product information into country-specific TF template

Controls the dossier configurations for internal review and external review

Manages changes and revisions to TFs and product information

Generates compliant submission documents in various HA/NB formats

Tracks & retains submission status& manage commitments

Decreases effort and calendar time to replicate regulatory submission between products and regulatory agencies

Provides clear oversight of original and life cycle submissions

RIM in future:

With the versatile and novel reporting requirements set out by regulatory authorities, the plea to need Regulatory Information Management System (RIMS) is emerging brassier.The medical device market is progressively adopting regulations for UDI, eIFU, electronic submissions, others. Making these things happen without a proper RIM system is very challenging.

At the same time, Medical device companies themselves are now realizing the strategically important role that various forms of product data could play in the future; enhancing new productivity, efficiency and create competitive differentiation.