MedDev Advisory Professional Knowledge Library

Medical Device Regulatory Handbooks for Evidence Decisions

Five decision-led practitioner books for ISO 10993 biological evaluation, chemistry-to-TRA, change control, CDSCO submission readiness and deficiency-response work. Inspect real 16-page previews before requesting a written offer.

Explore the Handbooks See Licence Prices
Cover of The Biological Evaluation Strategy Handbook Cover of Chemical Characterization to Toxicological Risk Assessment Cover of Medical Device Change Control and Evidence Decisions Cover of the CDSCO Medical Device Biological Safety Submission Playbook Cover of The Medical Device Submission Deficiency Response Fieldbook
5 current professional booksBiological safety, chemistry, change control, India and response work
Decision-led chaptersBuilt around professional work products and failure modes
Controlled source registersNamed, dated and governed title by title
From ₹14,900 / $179Transparent single-handbook pricing · applicable tax extra
Choose by decision

Choose the evidence decision you need to make

Start with the scope of the work—not the number of pages. Each book is designed for a different professional decision and links to a real public preview.

Cover of The Biological Evaluation Strategy Handbook
Available by written offer. First-edition purchase enquiries open.

The Biological Evaluation Strategy Handbook

A practical 201-page reference for ISO 10993-1:2025 biological evaluation, BEP and BER strategy, evidence fitness, chemistry, toxicology, testing, cross-market translation and lifecycle control.

Best forRA/QA and biological-safety professionals building or updating a BEP, BER or lifecycle strategy.
Helps you decideHow device facts, evidence, biological endpoints and jurisdiction context should connect in one defensible evaluation.

201 pages · 19 chapters · 19 original figures · 36 controlled source records

Individual current edition₹14,900 / $179Applicable tax extra
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Five current books · purchase enquiries open

Inspect the real pages, then request the exact offer

All five current editions are available by written offer. Their previews let you assess scope, method and professional boundaries first; an offer request creates no order or payment obligation.

Cover of Chemical Characterization to Toxicological Risk Assessment
Available by written offer. First-edition purchase enquiries open.

Chemical Characterization to Toxicological Risk Assessment

For regulatory, biological-safety and product-safety leads who must judge whether chemical-characterization evidence is fit for a qualified toxicological assessment and defensible BEP/BER integration.

161 pages · 18 chapters · 18 original figures · 6 appendices · 25 controlled source records

Individual current edition₹14,900 / $179Applicable tax extra
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Cover of Medical Device Change Control and Evidence Decisions
Available by written offer. First-edition purchase enquiries open.

Medical Device Change Control and Evidence Decisions

For QA, RA and cross-functional change boards that must reconstruct the approved baseline, assess cumulative impact, plan evidence and keep FDA, EU MDR and CDSCO route questions separate.

165 pages · 20 chapters · 20 original figures · 8 appendices · 29 controlled source records

Individual current edition₹14,900 / $179Applicable tax extra
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Cover of the CDSCO Medical Device Biological Safety Submission Playbook
Available by written offer. First-edition purchase enquiries open.

CDSCO Medical Device Biological Safety Submission Playbook

For India-focused regulatory, quality and biological-safety teams that must connect the applicable CDSCO route, Device Master File structure, device state and ISO 10993 evidence without collapsing distinct responsibilities.

184 pages · 15 chapters · 15 original figures · 7 appendices · 59 controlled source records

Individual current edition₹14,900 / $179Applicable tax extra
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Cover of The Medical Device Submission Deficiency Response Fieldbook
Available by written offer. First-edition purchase enquiries open.

The Medical Device Submission Deficiency Response Fieldbook

For regulatory and biological-safety teams that must interpret FDA Additional Information requests or EU notified-body questions, repair the underlying evidence chain, and control an answer through closure.

175 pages · 16 chapters · 16 original figures · 6 appendices · 23 controlled source records

Individual current edition₹14,900 / $179Applicable tax extra
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Transparent licence pricing

Choose one book—or the core three-book library

The single-book schedule applies to all five current titles. INR applies in India; USD is for eligible international requests and is confirmed in the written offer. Applicable tax is extra. Update Assurance lasts 12 months. No automatic renewal applies. The core bundle remains limited to the established first three titles; the CDSCO playbook and Fieldbook are purchased separately.

Any current book

Choose the title you need

One named current edition under the licence scope selected in your written offer.

LicenceCurrent edition+ 12-month updates
Individual₹14,900 USD $179₹19,900 USD $239
Organisation₹44,900 USD $549₹59,900 USD $749
Consultant practice₹74,900 USD $899₹99,900 USD $1,199
Choose a Book
Established library bundle

Core three-book professional library

Biological evaluation, chemistry-to-TRA and medical-device change control in one licence. The CDSCO playbook is separate.

LicenceCurrent editions+ 12-month updates
Individual₹34,900 Save ₹9,800₹46,900 Save ₹12,800
Organisation₹1,04,900 Save ₹29,800₹1,39,900 Save ₹39,800
Consultant practice₹1,74,900 Save ₹49,800₹2,29,900 Save ₹69,800
Request Core Library Offer

A request creates no order or payment obligation. The written offer confirms the exact edition, licensed files, holder, terms, tax treatment and controlled delivery before you decide.

Arvind Rathore, founder of MedDev Advisory
Author and editorial responsibility

Written for professional decisions—not generic reading

Arvind Rathore founded MedDev Advisory and works with medical-device teams on biological-evaluation strategy, BEP and BER documentation, chemistry-to-TRA interfaces, EU MDR technical documentation and FDA submission support.

Before establishing the practice, he was a Marie Skłodowska-Curie Early Stage Researcher at INSERM U1026 Biotis within the ImplantSens network. His work covered implantable electrochemical biosensors, cytotoxicity, oxidative stress, sterilization effects and biomaterial–cell interactions, with research placements in France, Germany and Sweden.

He holds an MTech in Biological Sciences and Bioengineering from IIT Kanpur and has peer-reviewed publications in Bioelectrochemistry, Advanced Sensor Research and Biochimie. Each handbook states where device-specific assessment or independent specialist judgment remains necessary.

Read the professional profile Review credentials and trust controls
Public maintenance record

Edition, source and correction status

Each title has a named version and a scheduled impact review. Material regulatory or scientific changes are assessed sooner when identified. A review date is a control point, not a promise that a new edition will be issued.

BookEdition / statusSource baselineNext control point
The Biological Evaluation Strategy Handbookv1.0.31 September 2026Event monitoring; next scheduled control point stated in the current release
Chemical Characterization to Toxicological Risk Assessmentv1.0.21 September 2026Event monitoring; next scheduled control point stated in the current release
Medical Device Change Control and Evidence Decisionsv1.0.21 September 2026Event monitoring; next scheduled control point stated in the current release
CDSCO Medical Device Biological Safety Submission Playbookv1.1.021 August 2026; targeted final-amendment check through 1 September 2026Event monitoring; next scheduled control point stated in the current release
The Medical Device Submission Deficiency Response Fieldbookv1.0.11 September 2026Event monitoring; next scheduled control point stated in the current release

Critical MedDev Advisory corrections to the purchased edition are provided without charge to the original licence holder. Eligible successor-edition updates depend on the written Update Assurance terms. Report a suspected publication issue to arvind.rathore@meddevadvisory.com.

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