MakroCare

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).

IVDR Performance evaluation
PEP IVDR
per performance evaluation report
performance evaluation ivdr

Comprehensive PMCF planning and post-market clinical follow-up (PMCF) solutions for medical devices. Your trusted PMCF partner.

pmcf medical device
pmcf studies

MakroCare provides Labeling services for Medical Device companies that span across Label creation, Label compliance, Artwork services, and review of IFU activities.

labeling medical devices
medical device labeling
medical device labeling requirements
eu mdr labeling requirements
mdr labeling requirements

MakroCare ensures compliance in medical device human factors validation testing, formative summative usability evaluations in support of pre-market FDA submissions.

usability testing medical device
usability testing services
fda europe usability testing
summative testing medical device

The EU In-Vitro Diagnostic Regulation (IVDR) implementation debates starting ahead of the GAP assessments. MakroCare experts guide you how to go about doing a systematic review of your technical documentation and QMS.

ivdr medical device
ivdr gap assessement
ivdr consulting service
ivdr remediation

Our Submission Services are designed to facilitate advanced publishing activities and to extend the capabilities of organizations while utilizing the eCTD format.

regulatory publishing services
regulatory submission services
regulatory publishing consultant
regulatory publishing outsourcing

Labeling Artwork Management solutions, such as local label alignment, labeling guidance, labeling strategy, core label updates, artwork creation and artwork pack management.

regulatory labeling services
regulatory labeling consultant
regulatory affairs labeling
new labelling regulations

CDISC Standard for Exchange of Nonclinical Data (SEND) services is the mandatory submission format for nonclinical animal data to the US FDA.

cdisc send services
New labeling regulations
fda send consulting
send nonclinical data conversion

Our global Medical Device Regulatory experts are well experienced in registrations and technical files management for regulatory authorities.

[[medical devices regualtory submission publishing
(https://www.makrocare.com/devices/regulatory/registrations-dossiers/)medical device submission consultant
Regulatory submission FDA 510k

MakroCare offers Regulatory Authorized Representative services & FDA authorization for Medical Device in the USA and UK. We make sure your product complies.

regulatory USA authorized representative
medical device Authorized representative UK
Authorized representative FDA