Logo of the company

RISK MANAGEMENT PLAN

Writer Approver
Name: Name:

Function: Function:

Date: Date:

Signature: Signature:

Company XXL Ltd ©

Address
page 1/
RISK MANAGEMENT PLAN
CONTENTS
Contents................................................................................................................................................2
I-Description of the product....................................................................................................................3
1.Description of the product(s)............................................................................................................3
2.Intended use....................................................................................................................................3
3.Classification of the device...............................................................................................................3
4.Applicable documents and references.............................................................................................3
II- Definition of responsibilities...............................................................................................................4
III- Identification of qualitative and quantitative characteristics related to the device .............................4
IV- Definition of the risk acceptability.....................................................................................................5
V- Control measures and verification activities........................................................................................7
VI- Requirements for reviewing the risk management documentation ....................................................7
VII- Post – production information..........................................................................................................8
VIII- Control of the document and changes.............................................................................................8

Medical device software and sterilization Ltd  +44 (0)7956789289

203 West street  patricia.vest@mdsspro.com
Fareham PO16 0EN. United Kingdom.
Reg: 10492707 page 2/
I-DESCRIPTION OF THE PRODUCT

1. DESCRIPTION OF THE PRODUCT(S)

A risk management plan has been created to address the ISO 14971:2012 requirements for the
Efisuture product family.
The Efisuture is a synthetic suture made of silk and available in the following size mentioned below:

Reference of the product Description of the product

Efi5.0 Sterile absorbable suture 5-0 according to
USP
Efi3.0 Sterile absorbable suture 3-0 according to
USP
Efi2.0 Sterile absorbable suture 2-0 according to
USP

The suture is provided with a stainless needle with the following diameter and length

Reference of the product Description of the product

Nee1.0 Sterile stainless needle 1 Gauge 10mm
Nee2.0 Sterile stainless needle 2 Gauge 10mm
Nee3.0 Sterile stainless needle 3 Gauge 10mm

2. INTENDED USE

The sutures are used for tissue approximation during general surgery or orthopedic surgery. The
devices are single use devices.

Medical device software and sterilization Ltd  +44 (0)7956789289

203 West street  patricia.vest@mdsspro.com
Fareham PO16 0EN. United Kingdom.
Reg: 10492707 page 2/
 3. CLASSIFICATION OF THE DEVICE

The Efisuture is used for a period of time that is less than 30 days. The product is a surgically
invasive device classified as Class IIb device under Rule 8, in accordance with the provisions of
Council Directive 93/42/EEC of 14 June, 1993 concerning medical devices.

Medical device software and sterilization Ltd  +44 (0)7956789289

203 West street  patricia.vest@mdsspro.com
Fareham PO16 0EN. United Kingdom.
Reg: 10492707 page 2/