Medical Device and IVD Consulting
Medical devices and in vitro diagnostics carry a documentation and evidence burden that few writing partners genuinely understand. Under the EU Medical Device Regulation (MDR 2017/745), the In Vitro Diagnostic Regulation (IVDR 2017/746), and India's Medical Devices Rules, 2017, manufacturers must build clinical and performance evidence, technical documentation, and post-market systems to exacting standards, and get them past Notified Bodies and regulators. EvySaif provides specialist consulting for exactly this work, with genuine delivered experience in device and IVD documentation.
A complete evidence and documentation partner
Our services span the full lifecycle: the clinical and performance evaluation that prove a product does what it claims, the technical documentation that assembles the evidence base for review, the study protocols that generate new data when existing evidence falls short, and the post-market systems that keep it current after launch. Because the same clinical and scientific team handles all of it, your documentation stays consistent from the first performance study to the post-market report.
Prove the product performs
Clinical Evaluation Plans and Reports (CEP and CER) under MDR Annex XIV, and IVD Performance Evaluation Plans and Reports (PEP and PER) under IVDR Annex XIII, establish that a device or diagnostic does what it claims.
Assemble the technical file
MDR and IVDR technical documentation, GSPR mapping, and Instructions for Use bring the whole evidence base into one coherent, reviewable file.
Generate new data when needed
Clinical investigation and performance study protocols to ISO 14155 and ISO 20916 produce the evidence that closes gaps existing data cannot.
Route to market and sustain it
Regulatory strategy for CE marking under the MDR and IVDR and for CDSCO registration in India, plus the post-market surveillance that keeps evidence current after launch.
Where we fit: we provide the evidence and documentation, working alongside your quality, testing, and manufacturing functions rather than replacing them. We do not run biocompatibility or bench testing, QMS certification audits, or a testing laboratory.
What we prepare
IVD Performance EvaluationPerformance Evaluation Plans and Reports (PEP and PER) under IVDR Annex XIII.
Medical Device Clinical EvaluationClinical Evaluation Plans and Reports (CEP and CER) under MDR Annex XIV.
Technical DocumentationMDR and IVDR technical files, GSPR mapping, and Instructions for Use.
Study protocolsClinical investigation and performance study documentation to ISO 14155 and ISO 20916.
Post-Market SurveillancePMS, PMCF and PMPF plans and reports, and PSURs.
CE marking and CDSCO strategyClassification, conformity routing, Notified Body support, and India MD Rules, 2017 documentation.
How EvySaif helps
We span the full device and IVD lifecycle with one clinical and scientific team, so your evidence and documentation stay consistent from first study to post-market report. We shape the regulatory strategy for CE marking and CDSCO registration, and prepare every document a Notified Body or regulator will read.
Why EvySaif
EvySaif is one of the best research and medical writing consultancies in India, and medical devices and IVDs are among our most concrete strengths. We have delivered clinical and analytical performance protocols and documentation for real diagnostic systems in Indian and European markets. Our work is clinician-led, so it reflects how a diagnostic result or a device actually drives a clinical decision, and it is written to withstand the scrutiny a Notified Body applies.
Frequently asked questions
No. We provide the evidence, documentation, and strategy, working alongside your quality, testing, and manufacturing functions. We do not run biocompatibility or bench testing, QMS certification audits, or a testing laboratory.
Yes. We prepare documentation and strategy for CE marking under the MDR and IVDR and for CDSCO registration under India's Medical Devices Rules, 2017.
Yes. The same clinical and scientific team handles evaluation, technical documentation, study protocols, and post-market work, which is what keeps the evidence consistent throughout.
Have a different question?
Tell us about your product, market, and timeline, and a clinician on our team will reply with specifics rather than a sales script.
Request a proposalExplore the device and IVD services
Preparing device or IVD documentation?
Tell us about your product and timeline, and we will come back with a scoped proposal for the dossier and strategy work.
Request a proposal