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Interested to know more about FDA QSR 21 CFR 820 Implementation or FDA 483 response support, please contact us.
FDA 21 CFR 820 - Quality System Regulation
21 CFR 820 is applicable to any finished medical device manufactured in the US or imported into and intended for use in the United States. 21 CFR 820 QMS is often known as the current good manufacturing practice (cGMP). Manufacturing, contract manufacturing, re-labeling, re-processing, and distributing medical devices are all covered under 21 CFR 820.
To ensure that their goods consistently fulfill applicable criteria and specifications, the company must establish and follow quality systems. We are 21 CFR 820 consultants, subject experts, and lead auditors who support worldwide customers.
- GMP Implementation support
- GMP Training
- Gap analysis audit
- Full or partial internal QSR audit
- Supplier audit
- FDA pre-inspection audit
- FDA QSR mock audit
- FDA Post Inspection Support for Closing 483’S
Applicability of 21 CFR 820 Regulation
Strict GMP / 21 CFR 820 regulation focus on class II or III devices and few class I medical device manufacturing – to ensure that finished devices will be safe and effective. The 21 CFR 820 regulation and strict GMP norms applicable for those detailed below.
- Note 1: Any device that is suitable for human use. No matter the condition of packaging, labelling and nature of sterility.
- Note 2: Any accessory suitable for human use such as blood tubing and diagnostic x-ray components.
21 CFR 820 Consultancy Fee
- Remote documentation of Quality Manual & Mandatory Procedure and relevant templates: 2500 USD in 14 working days (Basic information will be collected via email, and fine tuning must be done from customer end)
- Onsite Implementation by Interacting process owners by travelling to client location: 900 USD /person/man-day (Travel & Accommodation extra as per actuals)
- Understanding of FDA observation and preparing an action plan: 400 USD (Remote service) per each observation / 483. Onsite travelling and service charges extra)
- FDA Response preparation: 1000 USD
- Support in Closing Observation / 483’s: 2500 USD /man-day + travel & Accommodation
- Will be laid solid foundation for those who are implementing.
- Important document drafting
- Interaction with process owners and explanations of all processes
- IQA training and awareness
- Internal Audit Assistance
- FDA Pre-inspection GAP analysis.
§ 820.1 – Scope.
§ 820.3 – Definitions.
§ 820.5 – Quality system.
Subpart B – Quality System Requirements
§ 820.20 – Management responsibility.
§ 820.22 – Quality audit.
§ 820.25 – Personnel.
Subpart C – Design Controls
§ 820.30 – Design controls.
Subpart D – Document Controls
§ 820.40 – Document controls.
Subpart E – Purchasing Controls
§ 820.50 – Purchasing controls.
Subpart F – Identification and Traceability
§ 820.60 – Identification.
§ 820.65 – Traceability.
Subpart G – Production and Process Controls
§ 820.70 – Production and process controls.
§ 820.72 – Inspection, measuring, and test equipment.
§ 820.75 – Process validation.
Subpart H – Acceptance Activities
§ 820.80 – Receiving, in-process, and finished device acceptance.
§ 820.86 – Acceptance status.
Subpart I – Nonconforming Product
§ 820.90 – Nonconforming product.
Subpart J – Corrective and Preventive Action
§ 820.100 – Corrective and preventive action.
Subpart K – Labeling and Packaging Control
§ 820.120 – Device labeling.
§ 820.130 – Device packaging.
Subpart L – Handling, Storage, Distribution, and Installation
§ 820.140 – Handling.
§ 820.150 – Storage.
§ 820.160 – Distribution.
§ 820.170 – Installation.
Subpart M – Records
§ 820.180 – General requirements.
§ 820.181 – Device master record.
§ 820.184 – Device history record.
§ 820.186 – Quality system record.
§ 820.198 – Complaint files.
Subpart N – Servicing
§ 820.200 – Servicing.
Subpart O – Statistical Techniques
§ 820.250 – Statistical techniques.